[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87569-87570]
[FR Doc No: 2016-29097]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2896]

Public Meeting on Pre-Market Evaluation of Abuse-Deterrent
Properties of Opioid Drug Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the public meeting on Pre-Market Evaluation of
Abuse-Deterrent Properties of Opioid Drug Products that was announced
in the Federal Register on October 6, 2016. In that Federal Register
notice, FDA requested comments on the approach to testing FDA
recommended in its draft guidance ``General Principles for Evaluating
the Abuse Deterrence of Generic Solid Oral Opioid Drug Products'' and
FDA's efforts to develop standardized in vitro testing methodologies
for evaluating the abuse deterrence of opioid drug products. We are
taking this action in response to requests for an extension to allow
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the Public Meeting on
Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug
Products published October 6, 2016 (81 FR 69532). Submit either
electronic or written comments by January 3, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2896 for ``Public Meeting on Pre-Market Evaluation of Abuse-
Deterrent Properties of Opioid Drug Products; Extension of Comment
Period.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Division of Dockets Management
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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michelle Eby, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6184, Silver Spring, MD 20993, 301-796-
4714<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of October 6, 2016
(81 FR 69532), FDA published a notice announcing a public meeting and
requesting comments on the approach to testing FDA recommended in its
draft guidance ``General Principles for Evaluating the Abuse Deterrence
of Generic Solid Oral Opioid Drug Products'' \1\ and FDA's efforts to
develop standardized in vitro testing methodologies for evaluating the
abuse deterrence of opioid drug products. The comment period ends on
December 1, 2016. Because the Agency has received requests for an
extension to allow interested persons additional time to submit
comments, FDA is extending the comment period until January 3, 2017.
---------------------------------------------------------------------------

    \1\<EMAIL_ADDRESS>---------------------------------------------------------------------------

    Additional comments specific to the draft guidance ``General
Principles for Evaluating the Abuse Deterrence of Generic Solid Oral
Opioid Drug Products'' should be submitted to the docket for the draft
guidance (FDA-2016-D-0785) in lieu of, or in addition to, the docket
for the public meeting. 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 December 1, 2016. Other comments should be
submitted to this docket by January 3, 2016. FDA has committed to
taking steps to address the epidemic of opioid abuse transparently and
in close cooperation with stakeholders and will provide other
opportunities to comment, as appropriate. For example, FDA intends to
issue a general guidance for public comment describing the Agency's
recommendations for standardized in vitro testing to evaluate purported
abuse-deterrent properties and considerations for a potential applicant
as it develops an abuse-deterrent formulation of an opioid drug
product.

    Dated: November 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29097 Filed 12-2-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Proposed Rules]
[Pages 26373-26376]
[FR Doc No: 2019-11785]

========================================================================
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. 84, No. 109 / Thursday, June 6, 2019 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0404; Product Identifier 2019-NM-007-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2018-26-
07, which applies to all Airbus SAS Model A350-941 and -1041 airplanes.
AD 2018-26-07 requires repetitive greasing of the thrust reverser
actuators (TRAs), dispatch restrictions, and maintenance procedure
revisions. Since we issued AD 2018-26-07, we are now proposing to add a
requirement to replace the TRAs, which AD 2018-26-07 specified was not
required at the time to provide the opportunity for the public to
comment on the merits of that action. This proposed AD would require
actions specified in an European Aviation Safety Agency (EASA) AD,
which will be incorporated by reference. We are proposing this AD to
address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by July 22, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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 the material identified in this NPRM that will be incorporated
by reference (IBR), contact the EASA, Konrad-Adenauer-Ufer 3, 50668
Cologne, Germany; telephone +49 221 89990 1000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this IBR
material on the EASA website at https://ad.easa.europa.eu. You may view
this IBR material at the FAA, Transport Standards Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at http://www.regulations.gov.

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-2019-
0404; 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 NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, International Section, Transport Standards Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0404;
Product Identifier 2019-NM-007-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    We issued AD 2018-26-07, Amendment 39-19538 (83 FR 67677, December
31, 2018) (``AD 2018-26-07''), for all Airbus SAS Model A350-941 and -
1041 airplanes. AD 2018-26-07 requires repetitive greasing of the TRAs,
dispatch restrictions, and maintenance procedure revisions. AD 2018-26-
07 resulted from reports of the TRAs jamming. We issued AD 2018-26-07
to address jamming of the TRAs, which could lead to an inadvertent
thrust reverser sleeve deployment, possibly resulting in reduced
control or performance of the airplane.

Actions Since AD 2018-26-07 Was Issued

    The preamble to AD 2018-26-07 specifies that we consider the
requirements ``interim action'' and that we were considering requiring
a one-time replacement of affected (all part numbers) TRAs. That AD
explains that the planned compliance time for the installation of the
TRAs would allow enough time to provide notice and opportunity for
prior public comment on the merits of the replacement, and this
proposed AD follows from that determination.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0234R1, dated November 13, 2018
(``EASA AD 2018-0234R1'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A350-941 and -1041 airplanes. The
MCAI states:

    Operators of A350 aeroplanes have reported some occurrences of
TRA jamming. Further investigation results indicated that the ball
bearings inside the TRA are suffering from corrosion due to lack of
grease and are degrading with time.
    This condition, if not corrected, could lead to an inadvertent
thrust reverser sleeve deployment, possibly resulting in reduced
control or performance of the aeroplane.
    To address this potential unsafe condition, Airbus issued the
AOT [Alert Operators Transmission A78P001-18 Revision 01] to provide
instructions for repetitive TRA

greasing to prevent actuator ball bearings degradation, and the MER
[Major Event Revision] that incorporates temporary restrictions of
the MMEL [Master Minimum Equipment List] items related to thrust
reverser actuation system. The AOT also provides instructions to
replace certain affected TRA, depending on condition and previously
applied greasing.
    For the reasons described above, this [EASA] AD requires
implementation of certain dispatch restrictions. This [EASA] AD also
requires repetitive greasing of each affected TRA and a one-time
replacement of certain affected TRA, depending on condition.
* * * * *
    This [EASA] AD is still considered to be an interim action and
further AD action may follow.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2018-26-07, this proposed AD would retain all of the
requirements of AD 2018-26-07. Those requirements are referenced in
EASA AD 2018-0234R1, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related IBR Material Under 1 CFR Part 51

    This proposed AD would continue to require EASA AD 2018-0234R1,
which the Director of the Federal Register approved for incorporation
by reference as of January 15, 2019 (83 FR 67677, December 31, 2018).
This material 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.

FAA's Determination and Requirements of This 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 the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI referenced
above. We are proposing this AD because we evaluated all pertinent
information and determined an unsafe condition exists and is likely to
exist or develop on other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2018-0234R1 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD and except as discussed under
``Differences Between this Proposed AD and the MCAI/Service
Information.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA worked with Airbus and EASA to develop a process to
use certain EASA ADs as the primary source of information for
compliance with requirements for corresponding FAA ADs. As a result,
EASA AD 2018-0234R1 will be incorporated by reference in the FAA final
rule. This proposed AD would, therefore, require compliance with the
provisions specified in EASA AD 2018-0234R1, through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this proposed AD. Service information specified
in EASA AD 2018-0234R1 that is required for compliance with EASA AD
2018-0234R1 will be available on the internet http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0404 after the FAA final rule is published.

Differences Between This Proposed AD and the MCAI/Service Information

    The MCAI specifies to revise the EASA/Airbus MMEL to change certain
MMEL items. This proposed AD refers to the operator's minimum equipment
list (MEL) instead of the FAA MMEL. It is unnecessary to reference the
MMEL, as operators are required in 14 CFR part 91 to have an MEL to
operate with inoperable equipment and provisions for relief cannot be
in an MEL without first being part of the MMEL. The intent of the
provision has not changed.
    In addition, there are differences between the EASA/Airbus MMEL and
the FAA MMEL. The FAA MMEL is more restrictive because relief is
provided for only one engine reverser, whereas the EASA/Airbus MMEL
provides relief for both. Therefore, this proposed AD would require
incorporating the information specified in Figure 1 to paragraph (h)(4)
of this proposed AD into the operator's MEL.

Costs of Compliance

    We estimate that this proposed AD affects 11 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD                10 work-hours x $85 per               $0            $850          $9,350
 2018[dash]26[dash]07.                   hour = $850.
New proposed actions..................  12 work-hours x $85 per                *               *               *
                                         hour = $1,020.
----------------------------------------------------------------------------------------------------------------
* We have received no definitive data that would enable us to provide parts cost estimates for the replacement
  specified in this proposed AD.

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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

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 removing Airworthiness Directive (AD)
2018-26-07, Amendment 39-19538 (83 FR 67677, December 31, 2018), and
adding the following new AD:

Airbus SAS: Docket No. FAA-2019-0404; Product Identifier 2019-NM-
007-AD.

(a) Comments Due Date

    We must receive comments by July 22, 2019.

(b) Affected ADs

    This AD replaces AD 2018-26-07, Amendment 39-19538 (83 FR 67677,
December 31, 2018) (``AD 2018-26-07'').

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 78, Engine
Exhaust.

(e) Reason

    This AD was prompted by reports of thrust reverser actuators
(TRAs) jamming and the determination that a one-time replacement of
affected TRAs (all part numbers) is necessary. We are issuing this
AD to address jamming of the TRAs, which could lead to an
inadvertent thrust reverser sleeve deployment, possibly resulting in
reduced control or performance of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (EASA) AD 2018-
0234R1, dated November 13, 2018 (``EASA AD 2018-0234R1'').

(h) Exceptions to EASA AD 2018-0234R1

    (1) For purposes of determining compliance with the inspection
requirements of this AD: Where EASA AD 2018-0234R1 refers to its
effective date, this AD requires using January 15, 2019 (the
effective date of AD 2018-26-07).
    (2) For purposes of determining compliance with the TRA
replacement requirements of this AD: Where EASA AD 2018-0234R1
refers to its effective date, this AD requires using the effective
date of this AD.
    (3) Where EASA AD 2018-0234R1 refers to the master minimum
equipment list (MMEL), instead refer to the operator's minimum
equipment list (MEL).
    (4) Where EASA AD 2018-0234R1 refers to the flight operations
transmission (FOT) for certain changes, for this AD, do not
incorporate the information specified in EASA MMEL item 78-09-01B,
``ENG 1(2) REVERSER MINOR FAULT message--Associated reverser
considered inoperative,'' and instead, incorporate the information
specified in Figure 1 to paragraph (h)(4) of this AD into the
operator's MEL.
[GRAPHIC] [TIFF OMITTED] TP06JN19.004

    (5) The ``Remarks'' section of EASA AD 2018-0234R1 does not
apply to this AD.
    (6) Where EASA AD 2018-0234R1 refers to the ``the MER,'' that
document is not required by this AD, and it is not applicable to
U.S. operators.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2018-
0234R1 specifies to submit certain information to the manufacturer,
this AD does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this

AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the International Section, send
it to the attention of the person identified in paragraph (k)(2) of
this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2018-0234R1 that contains RC procedures and
tests: Except as specified by paragraph (j)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    (1) For information about EASA AD 2018-0234R1, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this EASA AD at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. EASA AD 2018-0234R1 may be found in the AD docket on
the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2019-0404.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
phone and fax:<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on May 28, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-11785 Filed 6-5-19; 8:45 am]
 BILLING CODE 4910-13-P


Maryland Department of the Environment

Air and Radiation Management Administration

Mobile Sources Control Program

Baltimore Nonattainment Area MOBILE6 Modeling Emission Analysis

Rate of Further Progress Runs

	Baltimore Area

Step

Modeling Scenario

VOC	NOx	 	Remarks

1

2002 RFP Base-Year Inventory

70.6	177.1	 	All 2002 control programs in place, 2002 VMT

	2

2002 RFP Adjusted Year Inventory

101.9	211.1	 	CAA Off, 7.8 RVP, 1990 I/M, 2002 Eval Yr & 2002 VMT

3

2008 RFP Adjusted Year Inventory

92.8	188.5	 	CAA Off, 7.8 RVP, 1990 I/M, 2008 Eval Yr & 2002 VMT

4

2009 RFP Adjusted Year Inventory

92.5	188.0	 	CAA Off, 7.8 RVP, 1990 I/M, 2009 Eval Yr & 2002 VMT

	7

2008 Projected Emission Inventory

41.2	106.8	 	All 2008 control programs in place

8

2009 Projected Emission Inventory

38.7	97.0	 	All 2009 control programs in place

9

2010 Projected Emission Inventory

36.3	85.5	 	All 2010 control programs in place

	2008 RFP Analysis

2008 Non-Creditables (Step 2 minus Step 3)

9.1	22.6

2008 Adjstd Base-Year minus Non-Creditables

83.7	165.9

2008 Target Emissions (w/15% Reductions)

71.1	141.0

2008 Target Emissions (w/18% Reductions)

68.6	136.1

	2008 Projctd Emissions (14% Projctd VMT Growth)

41.2	106.8

Notes:

	Emission modeling performed with PPSuite system designed for the state of MD, using the SHA-Count data to compute VMT

U.S. EPA's latest model MOBILE6.2 is built into the PPSuite system for producing the emission factors

Prepared by: MDE's Mobile Sources Control Program,                 Phone (410) 537-4183                                  January 26, 2007


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Page 52015]
[FR Doc No: 2012-21078]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-2496-000]

Emera Energy Services Subsidiary No. 10 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 proceeding,
of Emera Energy Services Subsidiary No. 10 LLC's application for
market-based rate authority, with an accompanying rate schedule, 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 September 10, 2012.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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 email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 21, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-21078 Filed 8-27-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 19, 2007 (Volume 72, Number 52)]
[Notices]
[Page 12788]
[DOCID:fr19mr07-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP04-98-002]

Indicated Shippers v. Columbia Gulf Transmission Company; Notice
of Compliance Filing

March 13, 2007.
    Take notice that on March 2, 2007, pursuant to the directive of the
Commission's Staff at the February 15, 2007 technical conference,
Columbia Gulf Transmission Company (Columbia Gulf) submits this filing
supplementing its proposal in the above referenced proceeding.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests 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 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>.

Philis J. Posey,
Acting Secretary.
 [FR Doc. E7-4994 Filed 3-16-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 82 (Tuesday, April 28, 2020)]
[Proposed Rules]
[Pages 23489-23492]
[FR Doc No: 2020-08976]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0342; Product Identifier 2019-SW-078-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus Helicopters Deutschland GmbH Model MBB-BK 117 D-2
helicopters. This proposed AD was prompted by a report of an erroneous
low rotor revolutions per minute (RPM) indication after establishing a
one engine inoperative (OEI) condition. This proposed AD would require
a software (SW) modification for the aircraft management computer
(AMC). The FAA is proposing this AD to address the unsafe condition on
these products.

DATES: The FAA must receive comments on this proposed AD by June 12,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus
Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone
972-641-0000 or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view this service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0342; 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 European Union Aviation Safety Agency (EASA) AD, any
comments received, and other information. The street address for Docket
Operations is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: George Schwab, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0342;
Product Identifier 2019-SW-078-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this NPRM.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2019-0208, dated August 22, 2019
(referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for all
Airbus Helicopters Deutschland GmbH Model MBB-BK 117 D-2 helicopters.
EASA advises that an occurrence was reported of erroneous low RPM
indication after establishing an OEI condition. To address this unsafe
condition, Airbus Helicopters developed upgraded AMC SW, which prevents
further occurrences, and issued service information providing
instructions to update the SW of affected parts.
    The FAA is issuing this AD to address erroneous low RPM
indications, which could cause the pilot to make inappropriate control
inputs, resulting in damage to the helicopter or injury to occupants.
    You may examine the MCAI in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0342.

Related Service Information Under 1 CFR Part 51

    Airbus Helicopters has issued Alert Service Bulletin MBB-BK117 D-2-
42A-005, Revision 3, dated June 6, 2019. This service information
describes procedures for a SW modification for the AMC.
    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.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
after evaluating all the relevant information and determining the
unsafe condition described previously is likely to exist or develop on
other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between this Proposed AD and the MCAI or Service
Information.''

Differences Between This Proposed AD and the MCAI or Service
Information

    EASA AD 2019-0208 provides a 60-day compliance time for
accomplishing the SW modification. This proposed AD would require
completion of the SW modification within 50 hours time-in-service.

Costs of Compliance

    The FAA estimates that this proposed AD affects 30 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................          $3,000           $3,085          $92,550
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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

    The FAA 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) Will not affect intrastate aviation in Alaska, and
    (3) 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 airworthiness
directive (AD):

Airbus Helicopters Deutschland GmbH: Docket No. FAA-2020-0342;
Product Identifier 2019-SW-078-AD.

(a) Comments Due Date

    The FAA must receive comments by June 12, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Helicopters Deutschland GmbH Model
MBB-BK 117 D-2 helicopters, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 42, Integrated
Modular Avionics.

(e) Reason

    This AD was prompted by a report of an erroneous low rotor
revolutions per minute (RPM) indication after establishing a one
engine inoperative condition. The FAA is issuing this AD to address
erroneous low RPM indications, which could cause the pilot to make
inappropriate control inputs, resulting in damage to the helicopter
or injury to occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Definitions

    (1) Affected part: An aircraft management computer (AMC) having
a software (SW) version installed that is identified as ``pre-
modification SW'' in Figure 1 to paragraphs (g)(1), (h), and (i) of
this AD, or earlier SW version.
[GRAPHIC] [TIFF OMITTED] TP28AP20.020

    (2) Group 1: Helicopters that have an affected part installed.
    (3) Group 2: Helicopters that do not have an affected part
installed.

(h) Software Modification

    (1) For Group 1: Within 50 hours time-in-service after the
effective date of this AD, update the SW of each affected part to
the corresponding upgraded SW, as listed in Figure 1 to paragraphs
(g)(1), (h), and (i) of this AD, in accordance with the
Accomplishment Instructions, Section 3.B.2, of Airbus Helicopters
Alert Service Bulletin MBB-BK117 D-2-42A-005, Revision 3, dated June
6, 2019.
    (2) Replacement on a helicopter of an affected part with an AMC
having the corresponding upgraded SW installed, as listed in Figure
1 to paragraphs (g)(1), (h), and (i) of this AD, or later SW upgrade
is an acceptable alternative method of compliance for the
requirements of paragraph (h)(1) of this AD for that helicopter.

(i) Parts Installation Prohibition

    Do not install on any helicopter an affected part, and do not
upload any SW identified as ``pre-modification SW'' in Figure 1 to
paragraphs (g)(1), (h), and (i) of this AD, or earlier SW version,
on any AMC, as required by paragraph (i)(1) or (2) of this AD, as
applicable.
    (1) For Group 1: After modification of that helicopter as
specified in paragraph (h) of this AD.
    (2) For Group 2: As of the effective date of this AD.

(j) 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:
George Schwab, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, 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.

(k) Related Information

    (1) The subject of this AD is addressed in European Union
Aviation Safety Agency (EASA) AD No. 2019-0208, dated August 22,
2019. This EASA AD may be found in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0342.
    (2) For service information identified in this AD, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html.
You may view this service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-
321, Fort Worth, TX 76177.

    Issued on April 23, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-08976 Filed 4-27-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Rules and Regulations]
[Pages 27709-27711]
[FR Doc No: 2018-12756]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0511]
RIN 1625-AA00

Safety Zone; Grosse Ile Yacht Club Fireworks, Detroit River,
Grosse Ile, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 280-foot radius of a portion of the Detroit
River, Grosse Ile, MI. This zone is necessary to protect spectators and
vessels from potential hazards associated with the Grosse Ile
Fireworks.

DATES: This temporary final rule is effective from 10 p.m. on June 30,
2018 through 11 p.m. on July 1, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0511 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Tracy Girard, Prevention Department,
Sector Detroit, Coast Guard; telephone<PHONE_NUMBER>, or email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Detroit
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
Coast Guard did not receive the final details of this fireworks display
in time to publish an NPRM. As such, it is impracticable to publish an
NPRM because we lack sufficient time to provide a reasonable comment
period and then consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would inhibit the Coast Guard's ability to protect
participants, mariners and vessels from the hazards associated with
this event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Detroit (COTP) has determined that
potential hazard associated with fireworks from 10 p.m. on June 30,
2018 through 11 p.m. on July 1, 2018 will be a safety concern to anyone
within a 280-foot radius of the launch site. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone while the fireworks are being displayed.

IV. Discussion of the Rule

    This rule establishes a safety zone from 10 p.m. on June 30 through
11 p.m. on July 1, 2018. The safety zone will encompass all U.S.
navigable waters of Detroit River, Grosse Ile, MI, within a 280-foot
radius of position 42[deg]05.390' N, 083[deg]09.065' W (NAD 83). The
safety zone will be enforced from 10 p.m. to 11 p.m. on June 30, 2018.
In the case of inclement weather on June 30, 2018, this safety zone
will be enforced from 10 p.m. to 11 p.m. on July 1, 2018. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits.

Executive Order 13771 directs agencies to control regulatory costs
through a budgeting process. This rule has not been designated a
``significant regulatory action,'' under Executive Order 12866.
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of the Detroit River from 10 p.m. on
June 30, 2018 through 11 p.m. on July 1, 2018. Moreover, the Coast
Guard will issue Broadcast Notice to Mariners (BNM) via VHF-FM marine
channel 16 about the zone and the rule allows vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a safety zone lasting one hour that will prohibit entry into a
designated area. It is categorically excluded from further review under
paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 01. A Record of Environmental Consideration supporting
this determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T09-0511 to read as follows:

Sec.  165.T09-0511   Safety Zone; Grosse Ile Yacht Club Fireworks,
Detroit River, Grosse Ile, MI.

    (a) Location. A safety zone is established to include all U.S.
navigable waters of the Detroit River, Grosse Ile, MI, within a 280-
foot radius of position 42[deg]05.390' N, 082[deg]09.065' W (NAD 83).
    (b) Enforcement period. The regulated area described in paragraph
(a) of this section will be enforced from 10 p.m. through 11:30 p.m. on
June 30, 2018. In the case of inclement weather on June 30, 2018, this
safety zone will be enforced from 10 p.m. to 11 p.m. on July 1, 2018.
    (c) Regulations. (1) No vessel or person may enter, transit
through, or

anchor within the safety zone unless authorized by the Captain of the
Port Detroit (COTP), or his on-scene representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or his on-scene representative.
    (3) The ``on-scene representative'' of COTP is any Coast Guard
commissioned, warrant or petty officer or a Federal, State, or local
law enforcement officer designated by or assisting the Captain of the
Port Detroit to act on his behalf.
    (4) Vessel operators shall contact the COTP or his on-scene
representative to obtain permission to enter or operate within the
safety zone. The COTP or his on-scene representative may be contacted
via VHF Channel 16 or at<PHONE_NUMBER>. Vessel operators given
permission to enter or operate in the regulated area must comply with
all directions given to them by the COTP or his on-scene
representative.

    Dated: June 6, 2018.
Jeffrey W. Novak,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2018-12756 Filed 6-13-18; 8:45 am]
 BILLING CODE 9110-04-P