Appendix 8A

MassDEP 2011 Mobile Source Emissions Projections - Methodology and Calculation

The methodology for developing the 2009 projected emissions is discussed in Section 9, Transportation Conformity.  As noted, the Massachusetts Executive Office of Transportation and Public Works, Office of Transportation and Planning (EOT), used a recently updated version of the Massachusetts Statewide Travel Demand Model (TDM) to estimate daily vehicle miles traveled (DVMT) and vehicle speeds.  Estimated emissions for 2009 are based on TDM runs performed by EOT using Mobile 6.2 emissions factors provided by MassDEP

Due to EOT staff resource constraints, the 2011 contingency projections are not based on an updated TDM run. Rather, MassDEP used data from an earlier TDM to project 2011 emissions. MassDEP took 2009 data generated from the prior version of the TDM  and compared this data to the results of the updated TDM.  It used the differences in the two-modeled outcomes to create a ratio to adjust 2011 projections as shown below.

MassDEP Calculation of 2011 On-Road Mobile Projections

	 2009 Conformity Budget using latest TDM	DEP 2009 estimates using prior version of TDM 	DIFF	% DIFF	DEP 2011 Emissions estimates using prior TDM DEP Adjusted 2011 estimates

 EMA DVMT (000s)	         135,657 	          138,007 	-2350	-1.7%

WMA DVMT (000s)	           24,838 	            26,293 	-1455	-5.5%

STATE DVMT (000s)	         160,495 	          164,300 	-3805	-2.3%

EMA VOC*  	63.50	61.90	-1.60	-2.6%	51.22	52.54

EMA NOX*

188.70	13.74	7.3%	142.46	132.09

WMA VOC	10.73	11.90	1.17	9.8%	9.82	8.85

WMA NOX	27.73	35.40	7.67	21.7%	26.72	20.93

STATE VOC	74.23	73.80	-0.43	-0.6%	61.04	61.40

STATE NOX	202.69	224.10	21.41	9.6%	169.18	153.02

ks/inv2002-sip-rfp nov/29-2007/ mhd-dep-vmt-diff2

*VOC and NOx are in tons per summer day.


[Federal Register Volume 87, Number 76 (Wednesday, April 20, 2022)]
[Rules and Regulations]
[Pages 23441-23444]
[FR Doc No: 2022-08425]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0233]
RIN 1625-AA00

Safety Zones; Cape Canaveral, Daytona, Tampa, Jacksonville, and
Tallahassee, Florida

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing five temporary safety zones
for the reentry of capsules launched by Space Exploration Technologies
Corporation (Space X) in support of the Axiom and the National
Aeronautics and Space Administration (NASA) Crew-3 capsule recovery
missions. These five temporary safety zones are located within the
Coast Guard District Seven area of responsibility offshore of Cape
Canaveral, Daytona, Jacksonville, Tampa, and Tallahassee, Florida. The
purpose of this rule is to ensure the safety of vessels, mariners, and
the navigable waters in the safety zones before, during, and after the
scheduled

event. This action is necessary to provide for the safe recovery of
these capsules and astronauts in our exclusive economic zone and
implements a special activities provision of the William M. (Mac)
Thornberry National Defense Authorization Act for Fiscal Year 2021.
This rule prohibits U.S. flagged vessels from being in the safety zones
unless authorized by the Commander of the Seventh Coast Guard District
or a designated representative.

DATES: This rule is effective without actual notice from April 20, 2022
through May 15, 2022. For purposes of enforcement, actual notice will
be used from April 17, 2022 until April 20, 2022.

ADDRESSES:  To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0233 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Stephanie Miranda, District 7
Waterways Division (dpw), U.S. Coast Guard; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
EEZ Exclusive Economic Zone
FR Federal Register
NASA National Aeronautics and Space Administration
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port
Space X Space Exploration Technologies Corporation

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 it is impracticable and contrary to
the public interest. The U.S. company, Space Exploration Technologies
Corporation (Space X) Axiom-1 and the National Aeronautics and Space
Administration (NASA) Crew-3 capsule recovery missions were approved
and scheduled less than 30 days before the need for the five safety
zones to be in place starting on April 17, 2022. Publishing an NPRM
would be impracticable and contrary to the public interest since the
missions would begin before completion of the rulemaking process,
thereby inhibiting the Coast Guard's ability to protect against the
hazards associated with the recovery missions.
    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 be impracticable and contrary to the public interest
because the temporary safety zones must be established on April 17,
2022, to mitigate safety concerns during the capsule recovery missions.

III. Legal Authority and Need for Rule

    On January 1, 2021, the William M. (Mac) Thornberry National
Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283)
(Authorization Act) was enacted. Its section 8343 (134 Stat. 4710)
calls for the Coast Guard to conduct a 2-year pilot program to
establish and implement a process to establish safety zones to address
special activities in the exclusive economic zone (EEZ).\1\ These
special activities include space activities carried out by United
States citizens. The Seventh District Commander, Captain of the Port
Jacksonville, and Captain of the Port St. Petersburg have determined
that potential hazards associated with the Space X Axiom-1 and the NASA
Crew-3 capsule recovery missions present a safety concern for anyone
within the perimeter of the five safety zones. The safety zones will
only be activated at a reasonable time before a recovery mission and
deactivated once the area is no longer hazardous. The purpose of this
rule is to ensure the safety of astronauts, vessels, mariners, and the
navigable waters in the safety zones before, during, and after the
scheduled event. The Coast Guard is issuing this rule under authority
of section 8343 of the Authorization Act and 46 U.S.C. 70034.
---------------------------------------------------------------------------

    \1\ The Coast Guard defines the exclusive economic zone in 33
CFR 2.30.
---------------------------------------------------------------------------

IV. Discussion of the Rule

    The Coast Guard is establishing five temporary safety zones. The
Space X Axiom-1 and Crew-3 recovery missions may occur within one of
the five following sites: Cape Canaveral, Daytona, Jacksonville, Tampa,
and Tallahassee, Florida. Based on mission and environmental factors,
Space X and NASA will determine which of the sites will be utilized
approximately one day before capsule reentry and recovery. The
appropriate safety zone will then be activated at a reasonable time
before the recovery mission and deactivated once the area is no longer
hazardous. Coast Guard District Eight may also establish temporary
safety zones for recovery missions in its respective area of
responsibility for these missions.
    The five temporary safety zones are listed below and include all
waters within the coordinates from surface to bottom. The coordinates
are based on the projected reentry locations as determined from
telemetry data and modeling by Space X.
    (1) Cape Canaveral site:

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

------------------------------------------------------------------------
Point 1.......................  29[deg]02'27'' N    080[deg]13'48'' W
Point 2.......................  28[deg]51'00'' N    080[deg]00'46'' W
Point 3.......................  28[deg]39'32'' N    080[deg]13'48'' W
Point 4.......................  28[deg]51'00'' N    080[deg]26'49'' W
Point 5.......................  29[deg]02'27'' N    080[deg]13'48'' W
------------------------------------------------------------------------

    (2) Daytona site:

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

------------------------------------------------------------------------
Point 1.......................  29[deg]59'27'' N    080[deg]35'59'' W
Point 2.......................  29[deg]48'00'' N    080[deg]22'51'' W
Point 3.......................  29[deg]36'32'' N    080[deg]35'59'' W
Point 4.......................  29[deg]48'00'' N    080[deg]49'08'' W
Point 5.......................  29[deg]59'27'' N    080[deg]35'59'' W
------------------------------------------------------------------------

    (3) Jacksonville site:

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

------------------------------------------------------------------------
Point 1.......................  31[deg]06'28'' N    080[deg]15'00'' W
Point 2.......................  30[deg]55'01'' N    080[deg]01'40'' W
Point 3.......................  30[deg]43'30'' N    080[deg]15'00'' W
Point 4.......................  30[deg]55'01'' N    080[deg]28'19'' W
Point 5.......................  31[deg]06'28'' N    080[deg]15'00'' W
------------------------------------------------------------------------

    (4) Tampa site:

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

------------------------------------------------------------------------
Point 1.......................  28[deg]17'27'' N    083[deg]54'00'' W
Point 2.......................  28[deg]06'00'' N    083[deg]41'02'' W
Point 3.......................  27[deg]54'32'' N    083[deg]54'00'' W
Point 4.......................  28[deg]06'00'' N    084[deg]06'57'' W
Point 5.......................  28[deg]17'27'' N    083[deg]54'00'' W
------------------------------------------------------------------------

    (5) Tallahassee site:

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

------------------------------------------------------------------------
Point 1.......................  29[deg]22'38'' N    084[deg]05'20'' W
Point 2.......................  29[deg]16'59'' N    083[deg]58'55'' W
Point 3.......................  29[deg]06'20'' N    084[deg]11'12'' W
Point 4.......................  29[deg]22'38'' N    084[deg]05'20'' W
------------------------------------------------------------------------

    When the safety zones are activated, the COTP or a designated
representative will be able to restrict vessel movement including but
not limited to transiting, anchoring, or mooring within the safety zone
to protect vessels from hazards associated with rocket and capsule
recovery missions. Active restrictions are based on mission specific
recovery

exclusion areas provided by Space X and NASA, are temporary in nature,
and would only be enacted and enforced at a reasonable time prior to
and after a recovery. Since the safety zones fall in the EEZ, only
United States flagged vessels are subject to safety zone enforcement.
The determination of risk would be at the discretion of the COTP and
informed by the mission specific recovery exclusion areas provided by
Space X and NASA.
    The COTP will inform the public of the activation or status of the
safety zones by Local Notice to Mariners and Broadcast Notice to
Mariners on VHF-FM channel 16.

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. 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).
    This regulatory action determination is based on the size,
location, duration, and scope of the safety zones. The safety zones are
limited in size and location to only those areas where capsule re-entry
is reasonably expected to occur. Of the five safety zones, only one may
will be activated for approximately two hours and only at a reasonable
time prior to re-entry, then deactivated once the area is no longer
hazardous. The safety zones are limited in scope, as vessel traffic
will be able to safely transit around the safety zones which will
impact a small part of the United States exclusive economic zone (EEZ)
within the Atlantic Ocean and Gulf of Mexico.

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.
    The total time of the safety zone activation and thus restriction
to the public is expected to be approximately two hours per capsule
recovery, of which two instances are projected during prior to the
expiration of this rule. Vessels would be able to transit around the
activated safety zone location during these recoveries. We do not
anticipate any significant economic impact resulting from activation of
the safety zones.
    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
call or email 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.

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, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), 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 the
establishing of five temporary safety zones, one of which may be
activated on two occasions for approximately two hours between April
17, 2022 and May 15, 2022 for a Space X and NASA mission. 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. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T07-0233 to read as follows:

Sec.  165.T07-0233  Safety Zones; Cape Canaveral, Daytona, Tampa,
Jacksonville, and Tallahassee, Florida.

    (a) Location. The following areas are safety zones:
    (1) Cape Canaveral site. All waters from surface to bottom
encompassed within the following coordinates connecting a line from
Point 1, thence to Point 2, thence to Point 3, thence to Point 4,
connecting back to Point 5:

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

------------------------------------------------------------------------
Point 1.......................  29[deg]02'27'' N    080[deg]13'48'' W
Point 2.......................  28[deg]51'00'' N    080[deg]00'46'' W
Point 3.......................  28[deg]39'32'' N    080[deg]13'48'' W
Point 4.......................  28[deg]51'00'' N    080[deg]26'49'' W
Point 5.......................  29[deg]02'27'' N    080[deg]13'48'' W
------------------------------------------------------------------------

    (2) Daytona site. All waters from surface to bottom encompassed
within the following coordinates connecting a line from Point 1, thence
to Point 2, thence to Point 3, thence to Point 4, connecting back to
Point 5:

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

------------------------------------------------------------------------
Point 1.......................  29[deg]59'27'' N    080[deg]35'59'' W
Point 2.......................  29[deg]48'00'' N    080[deg]22'51'' W
Point 3.......................  29[deg]36'32'' N    080[deg]35'59'' W
Point 4.......................  29[deg]48'00'' N    080[deg]49'08'' W
Point 5.......................  29[deg]59'27'' N    080[deg]35'59'' W
------------------------------------------------------------------------

    (3) Jacksonville site. All waters from surface to bottom
encompassed within the following coordinates connecting a line from
Point 1, thence to Point 2, thence to Point 3, thence to Point 4,
connecting back to Point 5:

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

------------------------------------------------------------------------
Point 1.......................  31[deg]06'28'' N    080[deg]15'00'' W
Point 2.......................  30[deg]55'01'' N    080[deg]01'40'' W
Point 3.......................  30[deg]43'30'' N    080[deg]15'00'' W
Point 4.......................  30[deg]55'01'' N    080[deg]28'19'' W
Point 5.......................  31[deg]06'28'' N    080[deg]15'00'' W
------------------------------------------------------------------------

    (4) Tampa site. All waters from surface to bottom encompassed
within the following coordinates connecting a line from Point 1, thence
to Point 2, thence to Point 3, thence to Point 4, connecting back to
Point 5:

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

------------------------------------------------------------------------
Point 1.......................  28[deg]17'27'' N    083[deg]54'00'' W
Point 2.......................  28[deg]06'00'' N    083[deg]41'02'' W
Point 3.......................  27[deg]54'32'' N    083[deg]54'00'' W
Point 4.......................  28[deg]06'00'' N    084[deg]06'57'' W
Point 5.......................  28[deg]17'27'' N    083[deg]54'00'' W
------------------------------------------------------------------------

    (5) Tallahassee site. All waters from surface to bottom encompassed
within the following coordinates connecting a line from Point 1, thence
to Point 2, thence to Point 3, connecting back to Point 4:

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

------------------------------------------------------------------------
Point 1.......................  29[deg]22'38'' N    084[deg]05'20'' W
Point 2.......................  29[deg]16'59'' N    083[deg]58'55'' W
Point 3.......................  29[deg]06'20'' N    084[deg]11'12'' W
Point 4.......................  29[deg]22'38'' N    084[deg]05'20'' W
------------------------------------------------------------------------

    (b) Definitions. As used in this section--
    Designated representative means Coast Guard Patrol Commanders
including Coast Guard coxswains, petty officers and other officers
operating Coast Guard vessels, Coast Guard Representatives in the
Merrill Operations Center, and Federal, state, and local officers
designated by or assisting the Captain of the Port (COTP) Jacksonville
and COTP St. Petersburg in the enforcement of the safety zones.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) The COTP Jacksonville and COTP St. Petersburg or a designated
representative may restrict vessel movement including but not limited
to transiting, anchoring, or mooring within these safety zones to
protect vessels from hazards associated with rocket recoveries. These
restrictions are temporary in nature and will only be enacted and
enforced prior to and just after the recovery missions.
    (3) Due to the safety zones falling within the United States
exclusive economic zone, only United States flagged vessels are subject
to safety zone enforcement. Other vessels are encouraged to remain
outside the safety zone.
    (4) Activation of a safety zone will be based on the risk
assessment of the COTP Jacksonville and COTP St. Petersburg and
informed by the mission specific recovery exclusion areas provided by
the Space Exploration Technologies Corporation and the National
Aeronautics and Space Administration to account for the specific risks
posed by individual recoveries.
    (d) Enforcement periods. This rule will be enforced from a
reasonable time before a recovery mission and deactivated once the area
is no longer hazardous between April 17, 2022 and May 15, 2022. The
COTP will inform the public of which safety zone will be activated by
Broadcast Notice to Mariners on VHF-FM channel 16.

    Dated: April 12, 2022.
Brendan C. McPherson,
Rear Admiral Commander, Seventh Coast Guard District.
[FR Doc. 2022-08425 Filed 4-18-22; 11:15 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Pages 85229-85231]
[FR Doc No: 2016-28334]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride;
Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a revised draft guidance for industry on
generic cyclobenzaprine hydrochloride extended release capsules,
entitled ``Draft Guidance on Cyclobenzaprine Hydrochloride.'' The
recommendations provide specific guidance on the design

of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for cyclobenzaprine hydrochloride extended release
capsules.

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 comments 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 January 24, 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-2007-D-0369 for ``Bioequivalence Recommendations for
Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' will be
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.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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    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 Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific BE recommendations and to provide a
meaningful opportunity for the public to consider and comment on those
recommendations. This notice announces the availability of revised
draft BE recommendations for generic cyclobenzaprine hydrochloride
extended release capsules.
    FDA initially approved new drug application 021777 for AMRIX
(cyclobenzaprine hydrochloride) extended release capsules in February
2007. In August 2008, FDA issued a draft guidance for industry on BE
recommendations for generic cyclobenzaprine hydrochloride extended
release capsules. We are now issuing a revised draft guidance for
industry on BE recommendations for generic cyclobenzaprine
hydrochloride extended release capsules (``Draft Guidance on
Cyclobenzaprine Hydrochloride'').
    In June 2016, Teva Pharmaceuticals Industries, Ltd. and its wholly-
owned subsidiaries, Teva Pharmaceuticals International GmbH, Teva
Pharmaceuticals USA, Inc., Teva Sales and Marketing, Inc., Teva Branded
Pharmaceutical Products R&D, Inc., and Cephalon, Inc., submitted a
citizen petition requesting that FDA take several actions with respect
to ANDAs for cyclobenzaprine hydrochloride extended release oral
capsules, including regarding the demonstration of BE for any ANDA
referencing AMRIX. FDA has reviewed the issues raised in this citizen
petition and is responding to the citizen petition separately in the
docket for that citizen

petition (Docket No. FDA-2016-P-1873, available at https://www.regulations.gov/).
    This revised 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 current thinking of FDA on the
design of BE studies to support ANDAs for cyclobenzaprine hydrochloride
extended release capsules. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the revised draft
guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov/.

    Dated: November 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28334 Filed 11-23-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 220 (Tuesday, November 15, 2011)]
[Notices]
[Pages 70715-70716]
[FR Doc No: 2011-29393]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC12-22-000.
    Applicants: Golden Winds Holding, LLC.
    Description: Golden Winds Holding, LLC Application for Approval
under Section 203 of the Federal Power Act and Request for Expedited
Action.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5217.
    Comment Date: 5 p.m. ET on 11/25/2011.

    Docket Numbers: EC12-23-000.
    Applicants: Entergy Nighthawk LP, LLC, Entergy Nighthawk GP, LLC,
FPLE Rhode Island State Energy, L.P., FPLE Rhode Island State Energy
GP, Inc., FPLE Rhode Island State Energy LP, LLC.
    Description: Application of FPLE Rhode Island State Energy, L.P.,
et al. for Section 203 Authorization.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5222.

    Comment Date: 5 p.m. ET on 11/25/2011.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER09-1286-005; ER09-1287-005; ER10-1362-002; ER11-
3620-001; ER11-2882-002; ER05-1218-006; ER05-1219-006; ER96-149-015;
ER10-71-003; ER00-2887-009; ER06-703-005; ER07-1341-006.
    Applicants: York Generation Company LLC, Dartmouth Power Associates
Limited Partnership, Camden Plant Holding, L.L.C., Newark Bay
Cogeneration Partnership, L.P, Elizabethtown Energy, LLC, Lumberton
Energy, LLC, Lyonsdale Biomass, LLC, Elmwood Park Power LLC, Hatchet
Ridge Wind, LLC, Pedricktown Cogeneration Company LP, ReEnergy Sterling
CT Limited Partnership, Bayonne Plant Holding, L.L.C.
    Description: Notification of Non-Material Change in Status.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5225.
    Comment Date: 5 p.m. ET on 11/25/2011.

    Docket Numbers: ER10-2651-002.
    Applicants: Lockhart Power Company.
    Description: Lockhart Power Company submits an Asset Appendix.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5070.
    Comment Date: 5 p.m. ET on 11/25/2011.

    Docket Numbers: ER10-2881-002; ER10-2882-002; ER10-2883-002; ER10-
2884-002; ER10-2885-002; ER10-2641-002; ER10-2663-002; ER10-2886-002.
    Applicants: Alabama Power Company, Southern Power Company,
Mississippi Power Company, Georgia Power Company, Gulf Power Company,
Oleander Power Project, LP, Southern Company--Florida LLC, Southern
Turner Cimarron I, LLC.
    Description: Supplement to Updated Market Power Analysis of
Southern Companies and their affiliates for the Southeast Region.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5182.
    Comment Date: 5 p.m. ET on 11/25/2011.

    Docket Numbers: ER12-354-000.
    Applicants: Carolina Power & Light Company.
    Description: Rate Schedule No. 121 of Carolina Power and Light
Company to be effective 1/4/2012.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5090.
    Comment Date: 5 p.m. ET on 11/25/2011.

    Docket Numbers: ER12-355-000.
    Applicants: Carolina Power & Light Company.
    Description: Rate Schedule No. 191 of Carolina Power and Light
Company to be effective 1/4/2012.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5094.
    Comment Date: 5 p.m. ET on 11/25/2011.

    Docket Numbers: ER12-356-000.
    Applicants: Florida Power & Light Company.
    Description: FPL Revision to Attachment H of the FPL OATT to be
effective 11/30/2011.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5185.
    Comment Date: 5 p.m. ET on 11/18/2011.

    Docket Numbers: ER12-357-000.
    Applicants: PacifiCorp.
    Description: PAC Energy NITSA Rev 10 to be effective 10/28/2011.
    Filed Date: 11/04/2011.
    Accession Number: 20111104-5197.
    Comment Date: 5 p.m. ET on 11/25/2011.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 7, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-29393 Filed 11-14-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42314-42318]
[FR Doc No: 2014-16920]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R10-OW-2014-0505; FRL-9913-96-Region-10]

Proposed Determination to Restrict the Use of an Area as a
Disposal Site; Pebble Deposit Area, Southwest Alaska

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and public hearing.

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SUMMARY: Pursuant to section 404(c) of the Clean Water Act (CWA), the
Environmental Protection Agency (EPA) Region 10 is requesting public
comments on its proposed determination to restrict the use of certain
waters in the South Fork Koktuli River (SFK), North Fork Koktuli River
(NFK), and Upper Talarik Creek (UTC) watersheds in southwest Alaska as
disposal sites for dredged or fill material associated with mining the
Pebble deposit, a copper-, gold-, and molybdenum-bearing ore body. EPA
Region 10 is also announcing a series of public hearings on this
section 404(c) proposed determination.

DATES: Submit comments on the proposed determination on or before
September 19, 2014. See PUBLIC HEARING section below for public hearing
dates and related information.

ADDRESSES: I. How to Obtain a Copy of the Proposed Determination: The
proposed determination is available primarily via the Internet on the
EPA Region 10 Bristol Bay site at www.epa.gov/bristolbay. Paper copies
are available upon request from either of the following locations:
     EPA Alaska Operations Office, 222 W 7th Avenue, Room 537,
Anchorage, AK 99513. The telephone number for this office is (907) 271-
5083.
     EPA Region 10, Public Environmental Resource Center, 1200
Sixth Avenue, Suite 900, Seattle, WA 98101. The telephone number for
this office is<PHONE_NUMBER> or<PHONE_NUMBER>.
    If you are requesting a paper copy, please provide your name, your
mailing address, and the document title, ``Proposed Determination of
the U.S. Environmental Protection Agency Region 10 Pursuant to Section
404(c) of the Clean Water Act; Pebble Deposit Area, Southwest Alaska.''
    II. How to Submit Comments to the Docket at www.regulations.gov:
Submit your comments, identified by Docket ID No. EPA-R10-OW-2014-0505,
by one of the following methods:
     Federal eRulemaking Portal (recommended method of comment
submission): Go to http://www.regulations.gov and follow the online
instructions for submitting comments.
     Email: Send email to<EMAIL_ADDRESS>Include the docket
number EPA-R10-OW-2014-0505 in the subject line of the message.
     Mail: Send your original comments and three copies to:
Water Docket, Environmental Protection Agency, Mail Code 2822T, 1200
Pennsylvania Avenue NW., Washington, DC 20460, Attention: Docket ID No.
EPA-R10-OW-2014-0505.
     Hand Delivery/Courier: Deliver your comments to EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Avenue NW., Washington,
DC 20460, Attention: Docket ID No. EPA-R10-OW-2014-0505. Such
deliveries are accepted only during the Docket's normal hours of
operation, 8:30 a.m. to 4:30 p.m. ET, Monday through Friday (excluding
legal holidays). Special arrangements should be made for deliveries of
boxed information. The telephone number for the Water Docket is (202)
566-2426.
     Submit at Public Hearing: see PUBLIC HEARINGS section
below.
    Instructions: EPA's policy is that all comments received will be
included in the public docket without change and will be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected information through
http://www.regulations.gov or email. The http://www.regulations.gov Web
site is an ``anonymous access'' system, which means EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to EPA without
going through http://www.regulations.gov, your email address will be
captured automatically and included as part of the comment that is
placed in the public docket and made publically available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA might not be able to consider your comment. Avoid
the use of special characters and any form of encryption, and ensure
that electronic files are free of any defects or viruses. For
additional information about EPA's public docket visit the EPA Docket
Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Some information, however, is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is publicly available only in hard copy. Publicly available
docket materials are available either electronically at http://www.regulations.gov or in hard copy at the Water Docket, EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Avenue NW., Washington,
DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m. ET,
Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the Water Docket is<PHONE_NUMBER>.
    Public Hearings: In accordance with EPA regulations at 40 CFR
231.4, the Regional Administrator determined that public hearings on
this section 404(c) proposed determination are in the public interest.
The hearing dates and locations are as follows:

August 12, 2014--2:00 p.m., Egan Center, Anchorage, Alaska
August 13, 2014--5:00 p.m., Nondalton, Alaska
August 13, 2014--5:00 p.m., New Stuyahok, Alaska
August 14, 2014--5:00 p.m., Dillingham, Alaska
August 14, 2014--5:00 p.m., Kokhanok, Alaska
August 15, 2014--12:00 p.m., Igiugig, Alaska
August 15, 2014--12:00 p.m., Iliamna, Alaska

    Additional hearing details and any changes to the schedule are
available at www.epa.gov/bristolbay. The purpose of the public hearings
is to obtain public testimony and comment on EPA Region 10's section
404(c) proposed determination regarding mining the Pebble deposit. The
Regional Administrator will designate the official who will preside at
the public hearing (the Presiding Officer). Any person may appear at
the hearing and submit oral and/or written statements or data and may
be represented by counsel or other authorized representatives. If you
would like to submit written comments you may do so at the public
hearings or by

one of the methods described in the section of this public notice
entitled: How to Submit Comments to the Docket at www.regulations.gov.
    Members of the public can sign up to make a comment at the venue on
the day of the meeting. The following information will be requested for
each commenter: First name, last name, organization and title (if
applicable), city, state, email address, and phone number. Tribal
elders and elected officials will be invited to comment first. The
facilitator will then use a random number system to select individuals
who signed up to determine speaking order. Audio-visual equipment will
not be provided.
    To maximize the number of individuals who are able to speak at the
hearing, oral statements may be limited to two minutes per person.
There will be no cross examination of any hearing participant, although
the Presiding Officer may make appropriate inquiries of any such
participant. The hearing will remain open, within reason, until
everyone who desires to speak has the opportunity.
    EPA Region 10 will not respond to questions/comments during the
hearing. EPA Region 10 will consider the oral and written statements
received at the public hearings and other written comments submitted
pursuant to the instructions set forth in the section of this public
notice entitled: How to Submit Comments to the Docket at
www.regulations.gov. Any person may present written statements for the
hearing file, including rebuttals to other commenter statements, prior
to the time the hearing file is closed to public submissions.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Water Docket; telephone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>For technical information concerning the proposed
determination, contact Judy Smith; telephone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>For more information about EPA's efforts in
Bristol Bay, copies of the section 404(c) proposed determination, or
copies of the Bristol Bay Assessment, see http://www.epa.gov/bristolbay.

SUPPLEMENTARY INFORMATION:

I. Information About the Proposed Determination

    The U.S. Environmental Protection Agency (EPA) Region 10 is
requesting public comment on a proposed determination to restrict the
use of certain waters in the Bristol Bay watershed for disposal of
dredged or fill material associated with mining the Pebble deposit, a
large ore body in southwest Alaska. EPA Region 10 is taking this step
because of the high ecological and economic value of the Bristol Bay
watershed and the assessed unacceptable environmental effects that
would result from such mining. This proposed determination relies on
clear EPA authorities under the Clean Water Act (CWA), and is based on
peer-reviewed scientific and technical information. Its scope is
geographically narrow and it does not affect other deposits or mine
claim holders outside of those affiliated with the Pebble deposit. EPA
Region 10 is taking this step pursuant to section 404(c) of the CWA and
its implementing regulations at 40 CFR part 231.
    Alaska's Bristol Bay watershed is an area of unparalleled
ecological value, boasting salmon diversity and productivity unrivaled
anywhere in North America. As a result, the region is a globally
significant resource with outstanding value. The Bristol Bay watershed
provides intact, connected habitats--from headwaters to ocean--that
support abundant, genetically diverse wild Pacific salmon populations.
These salmon populations, in turn, maintain the productivity of the
entire ecosystem, including numerous other fish and wildlife species.
    The Bristol Bay watershed's streams, wetlands, and other aquatic
resources support world-class, economically important commercial and
sport fisheries for salmon and other fishes, as well as a more than
4,000-year-old subsistence-based way of life for Alaska Natives. Each
year Bristol Bay supports the world's largest runs of sockeye salmon,
producing approximately half of the world's sockeye salmon. These
sockeye salmon represent the most abundant and diverse populations of
this species remaining in the United States. Bristol Bay's Chinook
salmon runs are frequently at or near the world's largest, and the
region also supports significant coho, chum, and pink salmon
populations. Because no hatchery fish are raised or released in the
watershed, Bristol Bay's salmon populations are entirely wild. Bristol
Bay is remarkable as one of the last places on Earth with such
bountiful and sustainable harvests of wild salmon. One of the main
factors leading to the success of this fishery is the fact that its
aquatic habitats are untouched and pristine, unlike the waters that
support many other fisheries.
    Nearly 70% of the sockeye and large numbers of the coho, Chinook,
pink, and chum salmon are harvested in commercial, subsistence, and
recreational fisheries before they can return to their natal lakes and
streams to spawn. Thus, these salmon resources have significant
economic, nutritional, cultural, and recreational value, both within
and beyond the Bristol Bay region. The Bristol Bay watershed's
ecological resources generated nearly $480 million in direct economic
expenditures and sales and provided employment for over 14,000 full-
and part-time workers in 2009. The Bristol Bay commercial salmon
fishery generates the largest component of this economic activity, with
an estimated value of $300 million (sales from fishers to processors)
and employment for over 11,000 full- and part-time workers (USEPA 2014:
Chapter 5).
    In February 2011, Northern Dynasty Minerals Ltd. (NDM) and the
Pebble Limited Partnership (PLP) formally submitted information to the
U.S. Securities and Exchange Commission (SEC) that put forth plans for
the development of a large-scale mine at the headwaters of this
pristine ecosystem. Their proposal outlines several stages of mine
development, the smallest being a 2.0-billion-ton mine \1\ and the
largest being a 6.5-billion-ton mine \2\ (Ghaffari et al. 2011, SEC
2011), both of which are larger than 90% of the known ore deposits of
this type in the world (USEPA 2014: Chapter 4).
---------------------------------------------------------------------------

    \1\ Ghaffari et al. (2011) call the 2.0 stage mine the
``Investment Decision Case,'' which describes an initial 25-year
open pit mine life upon which a decision to initiate permitting,
construction, and operations may be based.
    \2\ Ghaffari et al. (2011) call the 6.5 stage mine the
``Resource Case,'' which is based on 78 years of open pit production
and seeks to assess the long-term value of the project in current
dollars.
---------------------------------------------------------------------------

    The Pebble deposit is a large, low-grade, porphyry copper deposit
(containing copper-, gold-, and molybdenum-bearing minerals) that
underlies portions of the South Fork Koktuli River (SFK), North Fork
Koktuli River (NFK), and Upper Talarik Creek (UTC) watersheds. Based on
information provided by NDM and PLP to the SEC (Ghaffari et al. 2011,
SEC 2011), mining the Pebble deposit is likely to involve excavation of
the largest open pit ever constructed in North America, covering up to
6.9 square miles (17.8 km\2\) and reaching a depth of as much as 0.77
mile (1.24 km) (USEPA 2014: Chapter 6); for reference, the maximum
depth of the Grand Canyon is approximately 1 mile. Disposal of
resulting waste material would require construction of up to three mine
tailings impoundments covering an additional 18.8 square miles (48.6
km\2\) and waste rock piles covering up to 8.7 square miles (22.6
km\2\) (USEPA 2014: Chapter 6) in an area that

contains highly productive streams and wetlands. The volume of mine
tailings, and waste rock produced from the smallest mine proposed by
NDM/PLP to the SEC (Ghaffari et al. 2011, SEC 2011) would be enough to
fill a professional football stadium more than 800 times, whereas the
largest mine would do so more than 3,900 times.
    In total, these three mine components (mine pit, tailings
impoundments, and waste rock piles) would cover an area larger than
Manhattan. Mine construction and operation would also require the
construction of support facilities, including a major transportation
corridor, pipelines, a power-generating station, wastewater treatment
plants, housing and support services for workers, administrative
offices, and other infrastructure. Such facilities would greatly expand
the ``footprint'' of the mine and affect additional aquatic resources
beyond the scope of this proposed determination. Although NDM/PLP's
preliminary plans (Ghaffari et al. 2011, SEC 2011) could change, any
mining of this deposit would, by necessity, require similar mine
components, support facilities, and operational features.
    Given the extent of streams, wetlands, lakes, and ponds both
overlying the Pebble deposit and within adjacent watersheds, excavation
of a massive mine pit and construction of large tailings impoundments
and waste rock piles would result in discharge of dredged or fill
material into these waters. This discharge would result in complete
loss of fish habitat due to elimination, fragmentation, and dewatering
of streams, wetlands, and other aquatic resources. In addition, water
withdrawal and capture, storage, treatment, and release of wastewater
associated with the mine would significantly impair the fish habitat
functions of other streams, wetlands, and aquatic resources. All of
these losses would be irreversible.
    Based upon information known to EPA about the proposed mine at the
Pebble deposit and its potential impact on fishery resources, and as a
result of multiple inquires, concerns, and petitions to EPA to use its
authorities to protect these fishery resources, EPA decided to conduct
an ecological risk assessment before considering any additional steps.
After three years of study, two rounds of public comment, and
independent, external peer review, EPA released its Assessment of
Potential Mining Impacts on Salmon Ecosystems of Bristol Bay, Alaska
\3\ (the Bristol Bay Assessment) (USEPA 2014) in January 2014. The
Bristol Bay Assessment established that the extraction, storage,
treatment, and transportation activities associated with building,
operating and maintaining one of the largest mines ever built would
pose significant risks to the unparalleled ecosystem that produces one
of the greatest wild salmon fisheries left in the world. In simple
terms, the infrastructure necessary to mine the Pebble deposit
jeopardizes the long-term health and sustainability of the Bristol Bay
ecosystem.
---------------------------------------------------------------------------

    \3\ For more information about EPA's efforts in Bristol Bay or
copies of the Bristol Bay Assessment, see http://www.epa.gov/bristolbay.
---------------------------------------------------------------------------

    The Bristol Bay Assessment characterizes the significant ecological
resources of the region and describes potential impacts to salmon and
other fish from large-scale porphyry copper mining at the Pebble
deposit. The Bristol Bay Assessment evaluated these impacts using three
mine scenarios that represent different stages of mining at the Pebble
deposit, based on the amount of ore processed:
     Pebble 0.25 stage mine (approximately 0.25 billion tons of
ore over 20 years);
     Pebble 2.0 stage mine (approximately 2.0 billion tons of
ore over 25 years); and
     Pebble 6.5 stage mine (approximately 6.5 billion tons of
ore over 78 years).
    Ghaffari et al. (2011) indicate that the total mineral resources at
the Pebble deposit are now believed to be approximately 12 billion tons
of ore. Thus, it is expected that development of a mine at the Pebble
deposit would ultimately be much larger than the 0.25 stage mine and
could exceed the 6.5 stage mine. NDM has stated to the public that
``the Pebble deposit supports open pit mining utilizing conventional
drill, blast and truck-haul methods, with an initial mine life of 25
years and potential for mine extensions to 78 years and beyond'' (NDM
2011). This statement, along with others to investors, indicate that
NDM is actively considering a mine size between 2.0 and 6.5 billion
tons.
    Nevertheless, EPA also assessed the impacts of a much smaller mine
footprint in the Bristol Bay Assessment. The 0.25 stage mine is based
on the worldwide median size porphyry copper deposit (Singer et al.
2008). Although this smaller size is dwarfed by the mine sizes that
NDM/PLP put forward to the SEC (Ghaffari et al. 2011, SEC 2011), its
impacts would still be significant.
    In total, the Bristol Bay Assessment estimates that habitat losses
associated with the 0.25 stage mine would include nearly 24 miles (38
km) of streams, representing approximately 5 miles (8 km) of streams
with documented anadromous fish occurrence and 19 miles (30 km) of
tributaries of those streams (USEPA 2014: Chapter 7). Total habitat
losses would also include more than 1,200 acres (4.9 km\2\) of
wetlands, lakes, and ponds, of which approximately 1,100 acres (4.4
km\2\) are contiguous with either streams with documented anadromous
fish occurrence or tributaries of those streams. For the largest mine
that NDM/PLP put forward to the SEC (the 6.5 stage mine), stream losses
would expand to 94 miles (151 km), representing over 22 miles (36 km)
of streams with documented anadromous fish occurrence and 72 miles (115
km) of tributaries of those streams (USEPA 2014: Chapter 7). Total
habitat losses for the 6.5 stage mine would also include more than
4,900 acres (19.8 km\2\) of wetlands, lakes, and ponds, of which
approximately 4,100 acres (16.6 km\2\) are contiguous with either
streams with documented anadromous fish occurrence or tributaries of
those streams.
    To put these numbers in perspective, stream losses for just the
0.25 stage mine would equal a length of more than 350 football fields
and the 0.25 stage mine wetland losses would equal an area of more than
900 football fields. Although Alaska has many streams and wetlands that
support salmon, individual streams, stream reaches, wetlands, lakes,
and ponds play a critical role in protecting the genetic diversity of
Bristol Bay's salmon populations. Individual waters can support local,
unique populations (Quinn et al. 2001, Olsen et al. 2003, Ramstad et
al. 2010, Quinn et al. 2012). Thus, losing these populations would
erode the genetic diversity that is crucial to the stability of the
overall Bristol Bay salmon fisheries (Hilborn et al. 2003, Schindler et
al. 2010, USEPA 2014: Appendix A).
    These stream, wetland, and other aquatic resource losses also would
reverberate downstream, depriving downstream fish habitats of
nutrients, groundwater inputs, and other subsidies from lost upstream
aquatic resources. In addition, water withdrawal, capture, storage,
treatment, and release at even the 0.25 stage mine would result in
streamflow alterations in excess of 20% in more than 9 miles (nearly 15
km) of streams with documented anadromous fish occurrence. These
streamflow

changes would result in major changes in ecosystem structure and
function and would reduce both the extent and quality of fish habitat
downstream of the mine to a significant degree. The impacts from the
larger mine sizes NDM/PLP has forecasted would be significantly higher.
The 2.0 and 6.5 stage mines would result in streamflow alterations in
excess of 20% in more than 17 miles (27 km) and 33 miles (53 km),
respectively, of streams with documented anadromous fish occurrence
(USEPA 2014: Chapter 7).
    The CWA is a law essential for EPA's mission, which is to protect
and restore the environment and public health for current and future
generations. Section 404(c) of the CWA authorizes EPA to prohibit,
restrict, or deny the use of any defined area in waters of the United
States for specification as a disposal site whenever it determines,
after notice and opportunity for public hearing, that the discharge of
dredged or fill material into the area will have an unacceptable
adverse effect on fishery areas (including spawning and breeding
areas). EPA has used its section 404(c) authority judiciously and
sparingly, having completed only 13 section 404(c) actions in the 42-
year history of the CWA.
    As a first step in the regulatory process pursuant to section
404(c), EPA Region 10 coordinated with NDM/PLP and the State of Alaska
to provide them an opportunity to submit information that demonstrated
either that no unacceptable adverse effects would result from
discharges associated with mining the Pebble deposit or that actions
could be taken to prevent unacceptable adverse effects on fishery
areas. EPA Region 10 met with both NDM/PLP and the State and extended
the time period for both to submit this information.
    Both NDM/PLP and the State of Alaska submitted information that
raised scientific and technical issues, most of which had been
previously raised in public comments on the Bristol Bay Assessment.
However, this information did not demonstrate to the satisfaction of
EPA Region 10 that no unacceptable adverse effects on fishery areas
will occur should the disposal of dredged or fill material associated
with mining of the Pebble deposit proceed.
    Therefore, EPA Region 10 has decided to take the next step in the
section 404(c) review process, publication of this proposed
determination. As part of a section 404(c) proposed determination, the
EPA Regional Administrator must identify a defined area, known as the
disposal site, where its prohibitions or restrictions would apply. In
this case, the proposed geographic boundaries of the potential disposal
site are the waters within the mine claims held by NDM subsidiaries,
including PLP, that fall within the SFK, NFK, and UTC watersheds. EPA
Region 10 focused on this area because it determined that it best
represents the smallest geographical area where the discharge of
dredged or fill material associated with mining the Pebble deposit is
most likely to occur.
    To protect important fishery areas in the SFK, NFK, and UTC
watersheds from unacceptable adverse effects, EPA Region 10 recognizes
that losses of streams, wetlands, lakes, and ponds and alterations of
streamflow each provide a basis to issue this section 404(c) proposed
determination.
    Given the proposals made by NDM/PLP to develop 2.0- and 6.5-
billion-ton mines at the Pebble deposit (Ghaffari et al. 2011, SEC
2011) and EPA's evaluation of the 0.25-billion-ton mine (USEPA 2014),
the Regional Administrator has reason to believe that mining of the
Pebble deposit at any of these sizes, even the smallest, could result
in significant and unacceptable adverse effects on ecologically
important streams, wetlands, lakes, and ponds and the fishery areas
they support.
    Accordingly, the Regional Administrator proposes that EPA restrict
the discharge of dredged or fill material related to mining the Pebble
deposit into waters of the United States within the potential disposal
site that would, individually or collectively, result in any of the
following.

1. Loss of Streams

    a. The loss of 5 or more linear miles of streams with documented
anadromous fish \4\ occurrence; or
---------------------------------------------------------------------------

    \4\ Anadromous fish are those that hatch in freshwater habitats,
migrate to sea for a period of relatively rapid growth, and then
return to freshwater habitats to spawn. For the purposes of these
restrictions, anadromous fish refers to coho or silver (Oncorhynchus
kisutch), Chinook or king (O. tshawytscha), sockeye or red (O.
nerka), chum or dog (O. keta), and pink or humpback (O. gorbuscha)
salmon.
---------------------------------------------------------------------------

    b. The loss of 19 or more linear miles of streams where anadromous
fish are not currently documented, but that are tributaries of streams
with documented anadromous fish occurrence; or

2. Loss of Wetlands, Lakes, and Ponds

    The loss of 1,100 or more acres of wetlands, lakes, and ponds
contiguous with either streams with documented anadromous fish
occurrence or tributaries of those streams; or

3. Streamflow Alterations

    Streamflow alterations greater than 20% of daily flow in 9 or more
linear miles of streams with documented anadromous fish occurrence.
    These restrictions derive from the estimated impacts resulting from
the discharge of dredged or fill material associated with construction
and routine operation of a 0.25 stage mine at the Pebble deposit, as
evaluated in the Bristol Bay Assessment (USEPA 2014).
    EPA Region 10's evaluation of relevant portions of the section
404(b)(1) Guidelines (40 CFR part 230) further demonstrates that
discharge of dredged or fill material resulting in the level of adverse
effects identified in the proposed restrictions could result in
unacceptable adverse effects on fishery areas. Degradation of these
aquatic resources would be even more pronounced given extensive
cumulative impacts at successive stages of mine expansion (i.e., 2.0
and 6.5 stage mines or larger) at the Pebble deposit, including
elevated instream copper concentrations sufficient to cause direct
toxicity to fish. Toxic effects on fish would include fish kills;
reduced survival, growth, and/or reproduction; and reduced sensory
acuity, which is important to salmon for locating natal streams,
finding food, and avoiding predators.
    EPA Region 10 recognizes it has underestimated potential adverse
effects to resources within the SFK, NFK, and UTC watersheds from
mining the Pebble deposit for several reasons. This evaluation does not
include footprint impacts associated with all of the components
necessary to construct and operate such a mine (e.g., a major
transportation corridor, pipelines, a power-generating station,
wastewater treatment plants, housing and support services for workers,
administrative offices, and other infrastructure). It also does not
rely upon impacts resulting from potential accidents and failures as a
basis for its findings. There is a high likelihood that wastewater
treatment plant failures would occur, given the long management horizon
expected for the mine (i.e., decades). There is also real uncertainty
as to whether severe accidents or failures, such as a complete
wastewater treatment plant failure or a tailings dam failure, could be
adequately prevented over a management horizon of centuries, or even in
perpetuity, particularly in such a geographically remote area subject
to climate extremes. If such events were to occur, they would have
profound ecological ramifications. By not relying on potential
accidents and failures, EPA

Region 10 has employed a conservative analysis of adverse effects.
    Known compensatory mitigation techniques are unlikely to offset
impacts of the nature and magnitude described in the proposed
restrictions. Compensatory mitigation is the concept of improving
stream or wetland health in other parts of the watershed to compensate
for stream or wetland destruction or degradation in a separate area.
Compensatory mitigation efforts typically involve restoration and
enhancement of waters that have potential for improvement in ecological
services. However, the waters of the Bristol Bay watershed are already
among the most productive in the world. EPA Region 10 sees little
likelihood that human activity could improve upon the high quality
natural environment in the Bristol Bay watershed that nature has
created and has thus far been preserved. Compensation methods proposed
by PLP, including placement of in-stream structures, stream
fertilization, and construction of spawning channels, have typically
had only variable, local, or temporary effects, were designed for use
in degraded watersheds, or resulted in adverse, unintended consequences
(USEPA 2014: Appendix J).
    Mine alternatives with lower environmental impacts at the Pebble
deposit are not evaluated in either the Bristol Bay Assessment or this
section 404(c) proposed determination. If these proposed restrictions
are finalized, proposals to mine the Pebble deposit that have impacts
below each of these restrictions would proceed to the section 404
permitting process with the U.S. Army Corps of Engineers. Any such
proposals would have to meet the statutory and regulatory requirements
for permitting under section 404.
    After evaluating available information, EPA Region 10 has reason to
believe that unacceptable adverse effects on fishery areas (including
spawning and breeding areas) could result from the discharge of dredge
or fill material associated with mining the Pebble deposit. Further, it
has not been demonstrated to the satisfaction of EPA Region 10 that no
unacceptable adverse effect(s) will occur.
    EPA Region 10 is soliciting public comment on all issues discussed
in this proposed determination, including likely adverse impacts to
fishery resources, mitigation measures to potentially address these
impacts, and other options to restrict or prohibit potentially harmful
discharges of dredged or fill material associated with mining the
Pebble deposit. All comments will be fully considered as EPA Region 10
decides whether to withdraw the proposed determination or forward to
EPA Headquarters a recommended determination to restrict the use of
certain waters in the SFK, NFK, and UTC watersheds in southwest Alaska
as disposal sites for the discharge of dredged or fill material
associated with mining the Pebble deposit. Should EPA Region 10 make a
recommended determination, EPA Headquarters will then determine, based
on the recommended determination, public comments received on the
proposed determination, and all other available, relevant information,
whether to issue a final determination under section 404(c).

II. Solicitation of Comments on the Proposed Determination

    Please see the section above entitled ADDRESSES for information
about how to obtain a copy of the proposed determination and how to
submit comments on the proposed determination. EPA Region 10 is
soliciting comments on all issues discussed in the proposed
determination. In particular, we request:
    (1) Comments regarding whether the proposed determination should
become the recommended determination and ultimately the final
determination, and corrective action that could be taken to reduce the
adverse impact of the discharges.
    (2) Additional information on the likely adverse impacts on fish
and other ecological resources of the receiving waters that would be
directly or indirectly affected by mining the Pebble deposit (including
the SFK, NFK, and UTC and downstream reaches of the Nushagak and
Kvichak Rivers).
    (3) Additional information on the water quality, flora, fauna, and
hydrology of the waters identified in No. 2 above, and information on
the fish species that would be affected by aquatic ecosystem changes if
the discharges from the project occur.
    (4) Additional information about wildlife species that would be
affected if the discharges from the project occur.
    (5) Additional information about recreational uses of the project
area and how they would be impacted if the discharges from the project
occur.
    (6) Additional information about drinking water (including
municipal water supplies and private sources of drinking water such as
streams and/or wells) and how they would be impacted if the discharges
from the project occur.
    (7) Additional information on the potential for mitigation to be
successful in reducing the impacts of the project.
    (8) Comments regarding the approach used to define the potential
disposal site, including how EPA Region 10 weighed the factors
discussed in section 2.2.3 and whether there are other factors or
approaches EPA Region 10 should consider for defining the potential
disposal site.
    (9) Whether the discharge of dredged or fill material associated
with the project should be completely prohibited, restricted as
proposed, restricted in another manner, or not restricted at all at
this time. In particular, EPA Region 10 is also seeking comment on
whether environmental effects associated with other mine stages or
scenarios (e.g. environmental effects from mining approximately 2.0
billion tons of ore over 25 years) could provide a basis for
alternative or additional restrictions.
    (10) Comment on the definitions provided in Section 5.
    (11) Comment on whether and how EPA Region 10's action under
section 404(c) should consider discharge of dredged or fill materials
beyond those associated with the mine pit, tailings dam, and waste rock
piles, to include such discharges associated with the construction of
other mine infrastructure (e.g., wastewater treatment facilities,
transportation corridors, etc.).

All relevant data, studies, or informal observations are appropriate.
The record will remain open for comments until September 19, 2014. All
comments will be fully considered as EPA Region 10 decides whether to
withdraw the proposed determination or forward to EPA Headquarters a
recommended determination to restrict the use of certain waters in the
SFK, NFK, and UTC watersheds in southwest Alaska as disposal sites for
the discharge of dredged or fill material associated with mining the
Pebble deposit.

Dennis J. McLerran,
Regional Administrator, EPA Region 10.
[FR Doc. 2014-16920 Filed 7-18-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Rules and Regulations]
[Page 62454]
[FR Doc No: 2019-24821]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0868]

Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including
Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River, and
Calumet-Saganashkee Channel, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a segment of the Safety Zone;
Brandon Road Lock and Dam to Lake Michigan including Des Plaines River,
Chicago Sanitary and Ship Canal, Chicago River, Calumet-Saganashkee
Channel on all waters of the Chicago Sanitary and Ship Canal and South
Branch of the Chicago River between mile marker 296 and mile marker
296.7 during specified times from November 18, 2019 through November
22, 2019. This action is necessary and intended to protect the safety
of life and property on navigable waters prior to, during, and
immediately after planned US Army Corps of Engineers work at the
Electric Barrier. During the enforcement period listed below, entry
into, transiting, or anchoring within the safety zone is prohibited
unless authorized by the Captain of the Port Lake Michigan or a
designated representative.

DATES: The regulations in 33 CFR 165.930 will be enforced from 7 a.m.
through 1 p.m. and 3 p.m. through 5 p.m. from November 18, 2019, to
November 22, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LT Tiziana Garner, Waterways
Management Division, Marine Safety Unit Chicago, at<PHONE_NUMBER>, email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a segment of
the Safety Zone; Brandon Road Lock and Dam to Lake Michigan including
Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River,
Calumet-Saganashkee Channel, Chicago, IL, listed in 33 CFR 165.930.
Specifically, the Coast Guard will enforce this safety zone on all
waters of the Chicago Sanitary and Ship Canal between mile marker 296
and mile marker 296.7. Enforcement will occur from 7 a.m. through 1
p.m. and 3 p.m. to 5 p.m. from November 18, 2019 to November 22, 2019.
During the enforcement period, no vessel may transit this regulated
area without approval from the Captain of the Port Lake Michigan or a
designated representative. Vessels and persons granted permission to
enter the safety zone shall obey all lawful orders or directions of the
Captain of the Port Lake Michigan, or an on-scene representative.
    This notice of enforcement is issued under the authority of 33 CFR
165.930 and 5 U.S.C. 552(a). In addition to this publication in the
Federal Register, the Captain of the Port Lake Michigan will also
provide notice through other means, which will include Broadcast Notice
to Mariners, Local Notice to Mariners, distribution in leaflet form,
and on-scene oral notice. Additionally, the Captain of the Port Lake
Michigan may notify representatives from the maritime industry through
telephonic and email notifications. If the Captain of the Port or a
designated representative determines that the regulated area need not
be enforced for the full duration stated in this notice, he or she may
use a Broadcast Notice to Mariners to grant general permission to enter
the regulated area. The Captain of the Port Lake Michigan or a
designated on-scene representative may be contacted via Channel 16 or
at<PHONE_NUMBER>.

    Dated: November 1, 2019.
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2019-24821 Filed 11-14-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 167 (Tuesday, August 28, 2018)]
[Rules and Regulations]
[Pages 43742-43744]
[FR Doc No: 2018-18575]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0723; Product Identifier 2018-NE-17-AD; Amendment
39-19350; AD 2018-16-10]
RIN 2120-AA64

Airworthiness Directives; GE Aviation Czech s.r.o. Turboprop
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
GE Aviation Czech H80-200 turboprop engines. This AD requires replacing
the beta switch and adjusting the engine push-pull control to prevent
the propeller governor control from going to a negative thrust
position. This AD was prompted by an accident involving an Aircraft
Industries (AI) L 410 UVP-E20 airplane caused by one propeller going to
a negative thrust position during the landing approach. We are issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective September 12, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
12, 2018.
    We must receive comments on this AD by October 12, 2018.

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 service information identified in this final rule, contact GE
Aviation Czech s.r.o., Beranov[yacute]ch 65, 199 02 Praha 9--
Let[ncaron]any, Czech Republic; phone: +420 222 538 111; fax: +420 222
538 222. You may view this service information at the FAA, Engine and
Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803.
For information on the availability of this material at the FAA, call
781-238-7759. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0723.

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-2018-
0723; 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 final rule, the mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The address for Docket Operations (phone:<PHONE_NUMBER>) is
listed above. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7134; fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2018-0075, dated April 5, 2018 (referred to after this as ``the
MCAI''), to address an unsafe condition for the specified products. The
MCAI states:

    A fatal accident of an L 410 UVP-E20 aeroplane has been
reported. Preliminary investigation determined that there was an
annunciation of Beta mode on right hand engine, that the propeller
went inadvertently behind the fine pitch position and reached a
negative thrust position, and that the pitch lock system did not
intervene.
    This event occurred on approach at a speed and altitude which
did not allow the crew to recover this control system malfunction.
    This condition, if not corrected, could lead to reduced control
or loss of control of the aeroplane.
    To address this unsafe condition, GE Aviation Czech issued the
SB, providing modification instructions.
    For the reason described above, this [EASA] AD requires
modification of the engine. Addressing the same unsafe condition at
aeroplane level, EASA also issued AD 2018-0057, requiring
modification of affected AI L 410 UVP-E20 and L 410 UVP-E20 CARGO
aeroplanes, if equipped with GE Aviation H80-200 engines and Avia
Propeller AV 725 propellers.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2018-0723.

Related Service Information Under 1 CFR Part 51

    We reviewed GE Aviation Czech Service Bulletin (SB) SB-H80-76-00-
00-0036, Revision No. 02, dated March 29, 2018. The SB describes
procedures for inspecting and adjusting engine push-pull control, part
number (P/N) M601-76.3, and replacing beta switch, P/N P-S-2, with beta
switch, P/N P-S-2A. 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 EASA, and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of

the unsafe condition described in the MCAI and service information
referenced above. We are issuing this AD because we evaluated all the
relevant information provided by EASA and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

AD Requirements

    This AD requires adjusting the engine push-pull control and
replacing the beta switch to prevent the propeller governor control
going to a negative thrust position.

FAA's Justification and Determination of the Effective Date

    No domestic operators use this product. Therefore, we find good
cause that notice and opportunity for prior public comment are
unnecessary. In addition, for the reason stated above, we find that
good cause exists for making this amendment effective in less than 30
days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2018-
0723 and Product Identifier 2018-NE-17-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this final rule. We will
consider all comments received by the closing date and may amend this
final rule because of 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 final rule.

Costs of Compliance

    We estimate that this AD affects 0 engines installed on airplanes
of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspection, adjustment of the engine    8 work-hours x $85 per            $1,916          $2,596              $0
 push-pull control, and replacement of   hour = $680.
 beta switch.
----------------------------------------------------------------------------------------------------------------

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 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 engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

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 this AD:
    (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.

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):

2018-16-10 GE Aviation Czech s.r.o. (Type Certificate previously
held by WALTER Engines a.s., Walter a.s., and MOTORLET a.s.):
Amendment 39-19350; Docket No. FAA-2018-0723; Product Identifier
2018-NE-17-AD.

(a) Effective Date

    This AD is effective September 12, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to GE Aviation Czech H80-200 turboprop engines
with propeller governor part number, (P/N) P-W22-1, and Avia
Propeller AV-725 propellers installed. These engines are installed
on Aircraft Industries (AI) L 410 UVP-E20 and L 410 UVP-E20 CARGO
airplanes.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7600, Engine
Controls.

(e) Unsafe Condition

    This AD was prompted by an accident on an AI L 410 UVP-E20
airplane caused by one propeller going to a negative thrust position
during the landing approach. We are issuing

this AD to require engine modification to prevent asymmetric thrust.
The unsafe condition, if not addressed, could result in failure of
the beta switch, loss of engine thrust control, and reduced control
of the airplane.

(f) Compliance

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

(g) Required Actions

    Within 25 flight hours, 20 flight cycles, or 30 days, whichever
occurs first after the effective date of this AD, inspect and adjust
the engine push-pull control, P/N M601-76.3, and replace beta
switch, P/N P-S-2, with beta switch, P/N P-S-2A, in accordance with
paragraphs 1.6. and 1.7. of GE Aviation Czech Service Bulletin (SB)
SB-H80-76-00-00-0036, Revision No. 02, dated March 29, 2018.

(h) Installation Prohibition

    After the effective date of this AD:
    (1) Do not install beta switch, P/N P-S-2, on any engine.
    (2) Do not install a GE Aviation Czech H80-200 turboprop engine
on any airplane unless the required actions in paragraph (g) of this
AD have been complied with. This engine installation prohibition
does not apply to an engine removal and subsequent re-installation
on the same airplane during an airplane maintenance visit.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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 manager of the
certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD. You may email your
request to: [email protected].
    (2) 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.

(j) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Aviation Safety Agency AD 2018-0075, dated
April 5, 2018, for more information. You may examine the European
Aviation Safety Agency AD in the AD docket on the internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2018-0723.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) 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) GE Aviation Czech Service Bulletin SB-H80-76-00-00-0036,
Revision No. 02, dated March 29, 2018.
    (ii) Reserved.
    (3) For service information identified in this AD, contact GE
Aviation Czech s.r.o., Beranov[yacute]ch 65, 199 02 Praha 9--
Let[ncaron]any, Czech Republic; phone: +420 222 538 111; fax: +420
222 538 222.
    (4) You may view this service information at FAA, Engine &
Propeller Standards Branch, 1200 District Avenue, Burlington, MA
01803. 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 Burlington, Massachusetts, on August 21, 2018.
Karen M. Grant,
Acting Manager, Engine and Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2018-18575 Filed 8-27-18; 8:45 am]
 BILLING CODE 4910-13-P