[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6859-6861]
[FR Doc No: 2018-03129]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2326]

Determination of Regulatory Review Period for Purposes of Patent
Extension; FETZIMA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for FETZIMA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 14, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time

at the end of April 16, 2018. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-E-2326 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; FETZIMA.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product FETZIMA
(levomilnacipran hydrochloride). FETZIMA is indicated for treatment of
Major Depressive Disorder. Subsequent to this approval, the USPTO
received a patent term restoration application for FETZIMA (U.S. Patent
No. RE43879) from Pierre Fabre Medicament, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated November 3, 2015, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of FETZIMA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
FETZIMA is 1,602 days. Of this time, 1,298 days occurred during the
testing phase of the regulatory review period, while 304 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: March 8, 2009. FDA has verified the Pierre Fabre Medicament
claim that March 8, 2009, is the date the investigational new drug
application (IND) became effective.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: September
25, 2012. The applicant claims September 24, 2012, as the date the NDA
for FETZIMA was initially submitted. However, FDA records indicate that
new drug application (NDA) 204168 was submitted on September 25, 2012.
    3. The date the application was approved: July 25, 2013. FDA has
verified the applicant's claim that NDA 204168 was approved on July 25,
2013.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 954 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, as specified in Sec.  60.30
(21 CFR 60.30), any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period. To meet its burden,
the petition must comply with all the requirements of Sec.  60.30,
including but not limited to: Must be timely (see DATES), must be filed
in accordance with Sec.  10.20, must contain sufficient facts to merit
an FDA investigation, and must certify that a true and complete copy of
the petition has been served upon the patent applicant. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03129 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5189-5191]
[FR Doc No: 2019-02753]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Federal Motor Vehicle Theft
Prevention Standard; American Honda Motor Co., Inc.

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition for exemption.

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SUMMARY: This document grants in full the American Honda Motor Co.,
Inc.'s (Honda) petition for exemption of the 2020 Acura TLX vehicle
line in accordance with Exemption from Vehicle Theft Prevention
Standard. This petition is granted because the agency has determined
that the antitheft device to be placed on the line as standard
equipment is likely to be as effective in reducing and deterring motor
vehicle theft as compliance with the parts-marking requirements of the
Federal Motor Vehicle Theft Prevention Standard (Theft Prevention
Standard).

DATES: The exemption granted by this notice is effective beginning with
the 2020 model year (MY).

FOR FURTHER INFORMATION CONTACT: Ms. Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, West
Building, W43-439, NRM-310, 1200 New Jersey Avenue SE, Washington, DC
20590. Ms. Ballard's phone number is<PHONE_NUMBER>. Her fax number is
(202) 493-2990.

SUPPLEMENTARY INFORMATION: In a petition dated July 30, 2018, Honda
requested an exemption from the parts-marking requirements of the Theft
Prevention Standard for the Acura TLX vehicle line beginning with MY
2020. The petition requested an exemption from parts-marking pursuant
to 49 CFR part 543, Exemption from Vehicle Theft Prevention Standard,
based on the installation of an antitheft device as standard equipment
for the entire vehicle line.
    Under 49 CFR part 543.5(a), a manufacturer may petition NHTSA to
grant an exemption for one vehicle line per model year. In its
petition, Honda provided a detailed description and diagram of the
identity, design, and location of the components of the

antitheft device for the Acura TLX vehicle line. Honda stated that its
vehicle line will offer a front-wheel drive and an all-wheel drive
variation. Honda further stated that its MY 2020 Acura TLX vehicle line
will be installed with a transponder-based, engine immobilizer
antitheft device as standard equipment. More specifically, Honda stated
that the TLX vehicle line will be equipped with a ``smart entry push
button start'' ignition system (``smart entry'') and a vehicle security
alarm system as standard equipment on the entire vehicle line. Key
components of the antitheft device will include a passive immobilizer,
``smart entry'' remote, powertrain control module (PCM) and an
Immobilizer Entry System (IMOES).
    Honda's submission is considered a complete petition as required by
49 CFR 543.7, in that it meets the general requirements contained in
Sec.  543.5 and the specific content requirements of Sec.  543.6.
    In addressing the specific content requirements of Sec.  543.6,
Honda provided information on the reliability and durability of its
proposed device. To ensure reliability and durability of the device,
Honda conducted tests based on its own specified standards. Honda
provided a detailed list of the tests it used to validate the
integrity, durability, and reliability of its device and believes that
it follows a rigorous development process to ensure that its antitheft
device will be reliable and robust for the life of the vehicle. Honda
stated that its device does not require the presence of a ``smart
entry'' remote battery to function nor does it have any moving parts
(i.e., the PCM, IMOES, ignition key, ``smart entry'' remote and the
corresponding electrical components found within its own housing
units), which it believes reduces the chance for deterioration and wear
from normal use. Honda also stated that additional levels of
reliability, durability, and security will be accomplished because it
will incorporate counterfeit resistant vehicle identification number
(VIN) plates, secondary VINs, a hood release located inside the
vehicle, and its smart entry remote will utilize rolling codes for the
lock and unlock functions of its vehicles.
    Honda further stated that its immobilizer device is always active
without requiring any action from the vehicle operator as long as the
matching smart entry remote is outside of the operating range and the
engine is turned off. Deactivation occurs when a valid ``smart entry''
remote with matching codes is placed within operating range and the
engine start/stop button is pushed to start the vehicle. Honda further
states that if a ``smart entry'' remote without a matching code is
placed inside the operating range and the engine start/stop button is
pushed, the PCM will prevent fueling and starting of the engine.
Additionally, an ignition immobilizer telltale indicator will begin
flashing on the meter panel providing the status of the immobilizer
device.
    Honda stated that the audible and visible vehicle security alarm
system installed on its TLX vehicles will monitor any attempts of
unauthorized entry and attract attention to an unauthorized person
attempting to enter its vehicles without the use of a ``smart entry''
remote or its built-in mechanical door key. Specifically, Honda stated
that whenever an attempt is made to open one of its vehicle doors, hood
or trunk without using the ``smart entry'' remote or turning a key in
the key cylinder to disarm the vehicle, the vehicle's horn will sound,
and its lights will flash. Honda stated that its vehicle security
system is activated when all of the doors are locked and the hood and
trunk are closed and locked. Honda further stated that its vehicle
security system is deactivated by using the key fob buttons to unlock
the vehicle doors or having the ``smart entry'' remote within operating
range when the operator grabs either of the vehicle's front door
handles.
    In support of its belief that its antitheft device will be as or
more effective in reducing and deterring vehicle theft than the parts-
marking requirement, Honda referenced data showing several instances of
the effectiveness of its proposed immobilizer device. Honda first
installed an immobilizer device as standard equipment on its MY 2015
Acura TLX vehicles, which is also the year the TLX was first
introduced. There is no current theft rate data available for the Acura
TLX vehicle line. Additionally, Honda referenced the Highway Loss Data
Institute's 2015-2017's Insurance Theft Report showing the application
of years of the immobilizer that is currently available. Honda believes
that installation of the antitheft immobilizer device as standard
equipment reduces the vehicle theft rate by making conventional methods
of theft obsolete, i.e., punching out the steering column or hot-wiring
the ignition.
    Additionally, Honda stated that the immobilizer device proposed for
the 2018 TLX is similar to the design offered on its Honda Civic, Honda
Accord, Honda CR-V, Honda Pilot, and Acura MDX vehicles. The agency
granted the petition for the Honda Civic vehicle line in full beginning
with MY 2014 (see 61 FR 19363, March 29, 2013), the Honda Accord
vehicle line beginning with MY 2015 (see 79 FR 18409, April 1, 2014),
the Honda CR-V vehicle line beginning with MY 2016 (see 80 FR 3733,
January 23, 2015), the Honda Pilot beginning with MY 2017 (see 81 FR
12197, March 8, 2016), and the Acura MDX beginning with MY 2018 (see 82
FR 22055, May 11, 2017). The agency notes that the average theft rate
for the Honda Civic, Accord, CR-V, Pilot, and Acura MDX vehicle lines
using three MYs' data (MYs 2012 through 2014) are 0.6611, 0.7139,
0.3203, 0.9134, and 0.4630 respectively.
    Based on the supporting evidence submitted by Honda on its device,
the agency believes that the antitheft device for the Acura TLX vehicle
line is likely to be as effective in reducing and deterring motor
vehicle theft as compliance with the parts-marking requirements of the
Theft Prevention Standard (49 CFR 541). The agency concludes that the
device will provide the five types of performance listed in Sec.
543.6(a)(3): Promoting activation; attract attention to the efforts of
an unauthorized person to enter or move a vehicle by means other than a
key; preventing defeat or circumvention of the device by unauthorized
persons; preventing operation of the vehicle by unauthorized entrants;
and ensuring the reliability and durability of the device.
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7 (b), the agency grants
a petition for exemption from the parts-marking requirements of Part
541 either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of Part 541. The agency
finds that Honda has provided adequate reasons for its belief that the
antitheft device for the Acura TLX vehicle line is likely to be as
effective in reducing and deterring motor vehicle theft as compliance
with the parts-marking requirements of the Theft Prevention Standard.
This conclusion is based on the information Honda provided about its
device.
    The agency notes that 49 CFR part 541, Appendix A-1, identifies
those lines that are exempted from the Theft Prevention Standard for a
given model year. 49 CFR part 543.7(f) contains publication
requirements incident to the disposition of all Part 543 petitions.
Advanced listing, including the release of future product nameplates,
the beginning model year for which the

petition is granted and a general description of the antitheft device
is necessary in order to notify law enforcement agencies of new vehicle
lines exempted from the parts-marking requirements of the Theft
Prevention Standard.
    If Honda decides not to use the exemption for this line, it must
formally notify the agency. If such a decision is made, the line must
be fully marked according to the requirements under 49 CFR parts 541.5
and 541.6 (marking of major component parts and replacement parts).
    NHTSA notes that if Honda wishes in the future to modify the device
on which this exemption is based, the company may have to submit a
petition to modify the exemption. Part 543.7(d) states that a Part 543
exemption applies only to vehicles that belong to a line exempted under
this part and equipped with the antitheft device on which the line's
exemption is based. Further, Part 543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that Part
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend in drafting Part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if the
manufacturer contemplates making any changes, the effects of which
might be characterized as de minimis, it should consult the agency
before preparing and submitting a petition to modify.
    For the foregoing reasons, the agency hereby grants in full Honda's
petition for exemption for the Acura TLX vehicle line from the parts-
marking requirements of 49 CFR part 541, beginning with the 2020 model
year vehicles.

    Issued in Washington, DC, under authority delegated in 49 CFR
1.95 and 501.8.
Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2019-02753 Filed 2-19-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Notices]
[Pages 29611-29612]
[FR Doc No: 2021-11532]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92032; File No. SR-CboeBZX-2021-024]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To List and Trade Shares of the WisdomTree Bitcoin Trust Under
BZX Rule 14.11(e)(4), Commodity-Based Trust Shares

May 26, 2021.
    On March 26, 2021, Cboe BZX Exchange, Inc. (``BZX'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4

thereunder,\2\ a proposed rule change to list and trade shares of the
WisdomTree Bitcoin Trust under BZX Rule 14.11(e)(4), Commodity-Based
Trust Shares. The proposed rule change was published for comment in the
Federal Register on April 15, 2021.\3\ The Commission has received
comments on the proposed rule change.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 91521 (April 9,
2021), 86 FR 19917 (April 15, 2021).
    \4\ Comments received on the proposed rule change are available
at: https://www.sec.gov/comments/sr-cboebzx-2021-024/srcboebzx2021024.htm.
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    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days (i) as the Commission may
designate if it finds such longer period to be appropriate and
publishes its reasons for so finding or (ii) as to which the self-
regulatory organization consents, the Commission shall either approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether the proposed rule change
should be disapproved. The 45th day after publication of the notice for
this proposed rule change is May 30, 2021. The Commission is extending
this 45-day time period.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change and the
comments received. Accordingly, pursuant to Section 19(b)(2) of the
Act,\6\ the Commission designates July 14, 2021, as the date by which
the Commission shall either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-CboeBZX-2021-024).
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    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-11532 Filed 6-1-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 95 (Thursday, May 16, 2019)]
[Notices]
[Pages 22157-22158]
[FR Doc No: 2019-10204]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4429-DR; Docket ID FEMA-2019-0001]

Mississippi; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Mississippi (FEMA-4429-DR), dated April 23,
2019, and related determinations.

DATES: The declaration was issued April 23, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 23, 2019, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Mississippi resulting from severe storms, straight-line winds,
tornadoes, and flooding during the period of February 22 to March
29, 2019, is of sufficient severity and magnitude to warrant a major
disaster declaration under the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Mississippi.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Lai Sun Yee, of FEMA is appointed to
act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Mississippi have been
designated as adversely affected by this major disaster:

    Calhoun, Chickasaw, Clay, Grenada, Lowndes, Pontotoc, and
Tishomingo Counties for Public Assistance.
    All areas within the State of Mississippi are eligible for
assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,

Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-10204 Filed 5-15-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 103 (Friday, May 27, 2022)]
[Notices]
[Page 32225]
[FR Doc No: 2022-11375]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2022-0042]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on May 5, 2022, Goose Lake
Railway, LLC (GOOS), petitioned the Federal Railroad Administration
(FRA) for a waiver of compliance from certain provisions of the Federal
railroad safety regulations contained at 49 CFR part 240 (Qualification
and Certification of Locomotive Engineers) and part 242 (Qualification
and Certification of Conductors). FRA assigned the petition Docket
Number FRA-2022-0042.
    Specifically, GOOS requests relief as part of its proposed
implementation of and participation in FRA's Confidential Close Call
Reporting System (C\3\RS) Program. GOOS seeks to shield reporting
employees and the railroad from mandatory punitive sanctions that would
otherwise arise as provided in Sec. Sec.  240.117(e)(1)-(4);
240.305(a)(l)-(4) and (a)(6); 240.307; 242.403(b), (c), (e)(l)-(4),
(e)(6)-(11), (f)(l)-(2); and 242.407. The C\3\RS Program encourages
certified operating crew members to report close calls and protects the
employees and the railroad from discipline or sanctions arising from
the incidents reported per the C\3\RS Implementing Memorandum of
Understanding.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by July 11, 2022 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2022-11375 Filed 5-26-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: October 19, 2007 (Volume 72, Number 202)]
[Rules and Regulations]
[Page 59210-59213]
[DOCID:fr19oc07-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2007-0173;FRL-8484-2]

Determination of Attainment, Approval and Promulgation of
Implementation Plans and Designation of Areas for Air Quality Planning
Purposes; Indiana; Redesignation of Central Indiana To Attainment of
the 8-Hour Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On March 26, 2007, the Indiana Department of Environmental
Management (IDEM) submitted a request for EPA approval of a
redesignation of Boone, Hamilton, Hancock, Hendricks, Johnson, Madison,
Marion, Morgan, and Shelby Counties (the Central Indiana Area) to
attainment of the 8-hour ozone National Ambient Air Quality Standard
(NAAQS). IDEM also requested EPA approval of an ozone maintenance plan
for this area as a revision of the Indiana State Implementation Plan
(SIP). The maintenance plan demonstrates maintenance of the ozone NAAQS
in this area through 2020 and establishes 2006 and 2020 motor vehicle
Volatile Organic Compounds (VOC) and Nitrogen Oxides (NOX)
emission budgets for this area. EPA is making a determination that the
Central Indiana Area has attained the 8-hour ozone NAAQS. EPA is
approving, as a SIP revision, the State's ozone maintenance plan for
this area. Indiana has satisfied the criteria for the redesignation of
the Central Indiana Area to attainment of the 8-hour ozone NAAQS, and,
therefore, EPA is approving Indiana's ozone redesignation request for
this area. Further, EPA is approving, for purposes of transportation
conformity, the VOC and NOX Motor Vehicle Emission Budgets
(MVEBs) for 2006 and 2020 that are contained in the 8-hour ozone
maintenance plan. EPA proposed these actions on July 31, 2007, and
received only one comment in response supporting the proposed actions.

DATES: This final rule is effective on October 19, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
NO. EPA-R05-OAR-2007-0173. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index, some

information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet, and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at the

Environmental Protection Agency, Region 5, Air and Radiation Division,
77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. We recommend that you telephone Edward Doty,
Environmental Scientist, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Edward Doty, Environmental Scientist,
Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S.
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the following, whenever ``we,'' ``us,''
or ``our'' are used, we mean the United States Environmental Protection
Agency.

Table of Contents

I. What Is the Background for This Rule?
II. What Comments Did We Receive on the Proposed Action?
III. What Are Our Final Actions?
IV. Statutory and Executive Order Review.

I. What Is the Background for This Rule?

    The background for today's action is discussed in detail in EPA's
July 31, 2007, proposed rule (72 FR 41658). In that proposed rule, we
noted that, under EPA regulations at 40 CFR part 50, the 8-hour ozone
standard is attained in an area when the three-year average of the
annual fourth-highest daily maximum 8-hour average ozone concentrations
is less than or equal to 0.08 parts per million parts of air (ppm) at
all ozone monitoring sites in the area. (See 69 FR 23857 (April 30,
2004)).
    The Clean Air Act (CAA) requires EPA to designate as nonattainment
any area that is violating the 8-hour ozone NAAQS based on three
consecutive years of air quality monitoring data. EPA designated the
Central Indiana Area as a nonattainment area for the 8-hour ozone NAAQS
in a Federal Register notice published on April 30, 2004 (69 FR 23857).
At the same time, EPA classified the Central Indiana Area as a subpart
1 8-hour ozone nonattainment area, based on quality assured air quality
data for the period of 2001-2003.
    Under the CAA, a nonattainment area may be redesignated to
attainment if sufficient complete, quality-assured data are available
for the Administrator to determine that the area has attained the air
quality standard and if the area meets other redesignation requirements
in section 107(d)(3)(E) of the CAA. On March 26, 2007, Indiana
submitted a request for redesignation of the Central Indiana Area to
attainment of the 8-hour ozone NAAQS. The redesignation request
included three years of complete, quality-assured data for the period
of 2004-2006, indicating attainment of the 8-hour ozone NAAQS (we have
also reviewed available 2007 ozone data for this area, and, to date,
have seen no violations of the 8-hour ozone standard). The
redesignation request demonstrated that the Central Indiana Area had
met the redesignation criteria contained in the CAA. The redesignation
request included an ozone maintenance plan and documentation of 2006
and 2020 VOC and NOX MVEBs for this area. Our July 31, 2007,
proposed rule (72 FR 41658) provides a discussion of how the Central
Indiana Area and the State of Indiana have met the redesignation
requirements for this area.
    On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-
hour Ozone Standard. (69 FR 23951, April 30, 2004). South Coast Air
Quality Management Dist. v. EPA, 472 F.3d 882 (DC Cir. 2006). For the
reasons set forth in the July 31, 2007, proposed rule, EPA does not
believe that the Court's rulings alter any requirements relevant to
this redesignation action so as to preclude redesignation, and do not
prevent EPA from finalizing this redesignation.

II. What Comments Did We Receive on the Proposed Action?

    EPA provided a 30-day review and comment period. The comment period
closed on August 31, 2007. We received only one comment letter from the
City of Indianapolis, which supported our proposed approval of
Indiana's ozone redesignation request.

III. What Are Our Final Actions?

    EPA is taking several related actions for the Central Indiana Area.
First, EPA is making a determination that the Central Indiana Area has
attained the 8-hour ozone standard. EPA is approving Indiana's ozone
maintenance plan SIP revision for the Central Indiana Area. EPA is
approving the State's request to change the legal designation of the
Central Indiana Area from nonattainment to attainment of the 8-hour
ozone NAAQS. Finally, for the Central Indiana Area, EPA is approving
2006 MVEBs of 54.32 tons VOC per day and 106.19 tons NOX per
day and 2020 MVEBs of 29.52 tons VOC per day and 35.69 tons
NOX per day.
    In accordance with 5 U.S.C. 553(d), EPA finds that there is good
cause for these actions to become effective immediately upon
publication. This is because a delayed effective date is unnecessary
due to the nature of a redesignation to attainment, which relieves the
area from certain CAA requirements that would otherwise apply to it.
The immediate effective date for this action is authorized under both 5
U.S.C. 553(d)(1), which provides that rulemaking actions may become
effective less than 30 days after publication if the rule ``grants or
recognizes an exemption or relieves a restriction,'' and section
553(d)(3), which allows an effective date less than 30 days after
publication ``as otherwise provided by the agency for good cause found
and published with the rule.'' The purpose of the 30-day waiting period
prescribed in 553(d) is to give affected parties a reasonable time to
adjust their behavior and prepare before the final rule takes effect.
Today's rule, however, does not create any new regulatory requirements
such that affected parties would need time to prepare before the rule
takes effect. Rather, today's rule relieves the State of planning
requirements for this 8-hour ozone nonattainment area. For these
reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these
actions to become effective on the date of publication of these
actions.

IV. Statutory and Executive Order Review

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, therefore, is
not subject to review by the Office of Management and Budget.

Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant energy action,'' this action
is also not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001).

Regulatory Flexibility Act

    This action merely approves state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Redesignation of an area to attainment under
section 107(d)(3)(E) of the Clean Air Act does not impose any new
requirements on small entities. Redesignation is an action that affects
the status of a geographical area and does not impose any new
regulatory requirements on sources. Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).

Unfunded Mandates Reform Act

    Because this rule approves pre-existing requirements under state
law and does not impose any additional enforceable duty beyond that
required by State law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Order 13175: Consultation and Coordination with Indian Tribal
Governments

    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and

Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).

Executive Order 13132: Federalism

    This action also does not have Federalism implications because it
does not have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Redesignation is an action that merely affects the status of
a geographical area, and does not impose any new requirements on
sources, or allows a State to avoid adopting or implementing additional
requirements, and does not alter the relationship or distribution of
power and responsibilities established in the Clean Air Act.

Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks

    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it approves a State rule implementing a
Federal Standard.

National Technology Transfer Advancement Act

    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Redesignation is an
action that affects the status of a geographical area but does not
impose any new requirements on sources. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.

Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under Section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 18, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review, nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to force its requirements. (See Section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate matter, Volatile
organic compounds.

40 CFR Part 81

    Air pollution control, Environmental protection, National parks,
Wilderness areas.

    Dated: October 10, 2007.
Walter W. Kovalick, Jr.,
Acting Regional Administrator, Region 5.

0
Parts 52 and 81, chapter I, title 40 of the Code of Federal Regulations
are amended as follows:

PART 52--[AMENDED]

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

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

Subpart P--Indiana

0
2. Section 52.777 is amended by adding paragraph (jj) to read as
follows:

Sec.  52.777  Control strategy: Photochemical oxidants (hydrocarbons).

* * * * *
    (jj) Approval--On March 26, 2007, Indiana submitted a request to
redesignate Boone, Hamilton, Hancock, Hendricks, Johnson, Madison,
Marion, Morgan, and Shelby Counties (the Central Indiana Area)
(Indianapolis ozone nonattainment area) to attainment of the 8-hour
ozone National Ambient Air Quality Standard. As part of the
redesignation request, the State submitted an ozone maintenance plan as
required by section 175A of the Clean Air Act. Part of the section 175A
maintenance plan includes a contingency plan. The ozone maintenance
plan establishes 2006 motor vehicle emission budgets for the Central
Indiana Area of 54.32 tons per day for volatile organic compounds (VOC)
and 106.19 tons per day for nitrogen oxides (NOX) and 2020
motor vehicle emission budgets for the Central Indiana Area of 29.52
tons per day for VOC and 35.69 tons per day for NOX.

PART 81--[AMENDED]

0
3. The authority citation for part 81 continues to read as follows:

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

0
4. Section 81.315 is amended by revising the entries for Indianapolis,
Indiana: in the table entitled ``Indiana-Ozone (8-Hour Standard)'' to
read as follows:

Sec.  81.315  Indiana.

* * * * *

                                                            Indiana--Ozone (8-Hour Standard)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Designation \a\                                              Classification
        Designated area         ------------------------------------------------------------------------------------------------------------------------
                                            Date \1\                        Type                        Date \1\                        Type
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Indianapolis, IN:                October 19, 2007

    Boone County...............  .............................  Attainment..................
    Hamilton County............  .............................  Attainment..................
    Hancock County.............  .............................  Attainment..................
    Hendricks County...........  .............................  Attainment..................
    Johnson County.............  .............................  Attainment..................
    Madison County.............  .............................  Attainment..................
    Marion County..............  .............................  Attainment..................
    Morgan County..............  .............................  Attainment..................
    Shelby County..............  .............................  Attainment..................

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *

 [FR Doc. E7-20569 Filed 10-18-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 138 (Thursday, July 20, 2023)]
[Rules and Regulations]
[Pages 46687-46688]
[FR Doc No: 2023-15323]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0266; Airspace Docket No. 19-AAL-56]
RIN 2120-AA66

Establishment of United States Area Navigation (RNAV) Route T-388
in the Vicinity of Port Heiden, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes United States Area Navigation (RNAV)
T-route T-388, in the vicinity of Port Heiden, AK, in support of a
large and comprehensive T-route modernization project for the state of
Alaska.

DATES: Effective date 0901 UTC, October 5, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Steven Roff, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it expands the availability of RNAV in Alaska and improves
the efficient flow of air traffic within the National Airspace System
by lessoning the dependency on ground-based navigation.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2022-0266 in the Federal Register (87 FR 16674; March 24, 2022),
establishing RNAV T-route T-388, in the vicinity of Port Heiden, AK in
support of a large and comprehensive T-route modernization project for
the state of Alaska. Interested parties were invited to participate in
this rulemaking effort by submitting comments on the proposal. There
were no comments received.

Difference From the NPRM

    The NPRM misidentified the BAILY, AK, point as a waypoint (WP)
instead of a Fix. This rule corrects the error.

Incorporation by Reference

    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11, Airspace Designations and Reporting
Points, which is incorporated by reference in 14 CFR 71.1 on an annual
basis. This document amends the current version of that order, FAA
Order JO 7400.11G, dated August 19, 2022, and effective September 15,
2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. These amendments will be published
in the next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by establishing RNAV T-route T-
388 in the vicinity of Port Heiden, AK in support of a large and
comprehensive T-route modernization project for the state of Alaska.
The new route is described below.
    T-388: T-388 extends between the new WIXER, AK, WP, located over
the Port Heiden, AK (PDN), Non-Directional Beacon (NDB), and the BAILY,
AK, WP, located northwest of the Kodiak Airport, AK.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a

routine matter that only affects air traffic procedures and air
navigation, it is certified that this rule, when promulgated, does not
have a significant economic impact on a substantial number of small
entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this airspace action of establishing
RNAV route T-388 in the vicinity of Port Heiden, AK qualifies for
categorical exclusion under the National Environmental Policy Act (42
U.S.C. 4321 et seq.) and its implementing regulations at 40 CFR part
1500, and in accordance with FAA Order 1050.1F, Environmental Impacts:
Policies and Procedures, paragraph 5-6.5a, which categorically excludes
from further environmental impact review rulemaking actions that
designate or modify classes of airspace areas, airways, routes, and
reporting points (see 14 CFR part 71, Designation of Class A, B, C, D,
and E Airspace Areas; Air Traffic Service Routes; and Reporting
Points), and paragraph 5-6.5i, which categorically excludes from
further environmental review the establishment of new or revised air
traffic control procedures conducted at 3,000 feet or more above ground
level (AGL); procedures conducted below 3,000 feet AGL that do not
cause traffic to be routinely routed over noise sensitive areas;
modifications to currently approved procedures conducted below 3,000
feet AGL that do not significantly increase noise over noise sensitive
areas; and increases in minimum altitudes and landing minima. As such,
this action is not expected to result in any potentially significant
environmental impacts. In accordance with FAA Order 1050.1F, paragraph
5-2 regarding Extraordinary Circumstances, the FAA has reviewed this
action for factors and circumstances in which a normally categorically
excluded action may have a significant environmental impact requiring
further analysis. Accordingly, the FAA has determined that no
extraordinary circumstances exist that warrant preparation of an
environmental assessment or environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

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

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-388 WIXER, AK to BAILY, AK [New]

WIXER, AK                     WP                  (Lat. 56[deg]54'29.00'' N, long. 158[deg]36'10.00'' W)
ZOPAB, AK                     WP                  (Lat. 57[deg]09'28.12'' N, long. 157[deg]48'14.87'' W)
HEBMI, AK                     WP                  (Lat. 57[deg]24'13.13'' N, long. 156[deg]51'24.77'' W)
ZEMIR, AK                     WP                  (Lat. 57[deg]51'13.88'' N, long. 154[deg]02'28.16'' W)
BAILY, AK                     Fix                 (Lat. 57[deg]54'33.79'' N, long. 152[deg]54'36.97'' W)

* * * * *

    Issued in Washington, DC, on July 13, 2023.
Karen L. Chiodini,
Manager, Airspace Rules and Regulations.
[FR Doc. 2023-15323 Filed 7-19-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Page 26014]
[FR Doc No: 2015-10567]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14628-001--Minnesota A-Mill Artist Lofts Hydroelectric
Project]

Minneapolis Lease Housing Associates IV, Limited Partnership;
Notice of Revised Restricted Service List for a Programmatic Agreement
for Managing Properties Included In or Eligible for Inclusion in the
National Register of Historic Places

    On February 18, 2018, the Federal Energy Regulatory Commission
(Commission) issued notice of a proposed restricted service list for
the preparation of a programmatic agreement for managing properties
included in, or eligible for inclusion in, the National Register of
Historic Places at the proposed A-Mill Artist Lofts Hydroelectric
Project No. 14628-001 (A-Mill Project). Rule 2010(d)(1) of the
Commission's Rules of Practice and Procedure, 18 CFR 385.2010(d)(1)
(2014), provides for the establishment of such a list for a particular
phase or issue in a proceeding to eliminate unnecessary expense or
improve administrative efficiency. Under Rule 385.2010(d)(4), persons
on the official service list are to be given notice of any proposal to
establish a restricted service list and an opportunity to show why they
should also be included on the restricted service list or why a
restricted service list should not be established.
    On April 7, 2015, Amy Burnette, Tribal Historic Preservation
Officer for the Leech Lake Band of Ojibwe, filed a letter stating that
the Leech Lake Band of Ojibwe does not have any known recorded sites of
religious or cultural importance in the proposed project boundary, but
they would like to be informed if any human remains or cultural
importance objects are discovered.
    On February 20, 2015, the city of Minneapolis, requested to be a
consulting party in that section 106 on the National Historic
Preservation Act process so that it may stay apprised and provide
project input.
    Under Rule 385.2010(d)(2), any restricted service list will contain
the names of each person on the official service list, or the person's
representative, who, in the judgment of the decisional authority
establishing the list, is an active participant with respect to the
phase or issue in the proceeding for which the list is established. The
Leech Lake Band of Ojibwe and the city of Minneapolis have identified
an interest in issues relating to the management of historic properties
at the A-Mill Project. Therefore, they and their representatives will
be added to the restrictive service list.
    Accordingly, the restricted service list issued on February 18,
2015, for the A-Mill Artist Lofts Project No. 14628 is revised to add
the following persons:
    Amy Burnette or representative, Division of Resource Management,
Leech Lake Tribal Historic Preservation Office, 190 Sailstar Drive NE.,
Cass Lake, MN 56633.
    Haila Maze, AICP, or representative, City of Minneapolis, Community
Planning and Economic Development, 105 Fifth Avenue South--200,
Minneapolis, MN 55401-2534.

    Dated: April 29, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-10567 Filed 5-5-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 32047-32048]
[FR Doc No: 2017-14405]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2017-42]

Petition for Exemption; Summary of Petition Received; Ela
Aviation USA

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

ACTION: Notice

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

DATES: Comments on this petition must identify the petition docket
number and must be received on or before July 31, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0569
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE., Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in

Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

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

    Issued in Washington, DC, on June 20, 2017.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2017-0569.
    Petitioner: Ela Aviation USA.
    Section(s) of 14 CFR Affected: 21.181, 21.190.
    Description of Relief Sought: Petitioner seeks exemption from the
requirements of Title 14 of the Code of Federal Regulations (CFR)
Sec. Sec.  21.181 and 21.190 for the issuance of a special
airworthiness certificate in the light-sport category to operate the
ELA 10-Eclipse Gyroplane. The proposed exemption will permit the ELA
10-Eclipse Gyroplane to be certificated, operated, and maintained under
the regulations applicable to aircraft issued a special airworthiness
certificate in the light-sport category within the National Airspace
System (NAS).

[FR Doc. 2017-14405 Filed 7-10-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 28, 2008 (Volume 73, Number 40)]
[Notices]
[Page 10837-10839]
[DOCID:fr28fe08-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57357; File No. SR-CBOE-2008-14]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change To Establish a
Solicitation Auction Mechanism and To Amend Its Automated Improvement
Mechanism

February 20, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 7, 2008, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which items have been substantially
prepared by the CBOE. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to establish a new automated mechanism for auctioning
larger-sized orders and to modify its existing automated improvement
mechanism (``AIM'') to permit its use for the execution of complex
orders. The text of the proposed rule change is available on the
Exchange's Web site at (http://www.cboe.org/Legal), at the Office of
the Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Under CBOE Rules 6.45A, Priority and Allocation of Equity Option
Trades on the CBOE Hybrid System, and 6.45B, Priority and Allocation of
Trades in Index Options and Options on ETFs on the CBOE Hybrid System,
order entry firms that electronically enter orders are required to
expose an unsolicited agency order (``Agency Order'') for at least 3
seconds before crossing it against an order that it has solicited from
other broker-dealers.\3\ Currently, an order entry firm can comply with
this requirement by entering the Agency Order on the Exchange, waiting
3 seconds, and then entering the solicited order. The Exchange states
that, due to the 3-second exposure requirement, order entry firms have
no level of assurance that they will be able to electronically pair
solicited orders against Agency Orders for executions. As an
alternative, CBOE has developed AIM, which permits an Agency Order to
be electronically executed against principal or solicited interest.\4\
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    \3\ See CBOE Rule 6.45A.02 and 6.45B.02.
    \4\ See CBOE Rule 6.74A, Automated Improvement Mechanism
(``AIM'').
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    To better compete with various other electronic alternatives
available at other options exchanges, CBOE has also developed an
enhanced auction mechanism for larger-sized simple and complex Agency
Orders that are to be executed against solicited orders (the
``Auction''). The proposed rule change would implement this
functionality in options classes designated by the Exchange. Such
orders would be required to be for at least 500 contracts, must be
entered as all-or-none limit (``AON'') orders,\5\ and would be executed
only if the price is at or better than the CBOE best bid or offer
(``BBO'').
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    \5\ The Exchange's existing rules provide that an AON order may
be crossed with another AON order if all bids or offers at the same
price at which the cross is to be effected have been filled. See,
e.g., Interpretation and Policy .01 to CBOE Rule 6.44, Bids and
Offers in Relation to Units of Trading. The proposed Auction system
is modeled after this principle, except that it would allow the
crossing of large-sized AON orders to take place so long as there
are no public customer orders at the proposed price and there is
insufficient size at an improved price to accommodate the Agency
Order.
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    When a proposed solicited cross is entered into the Auction, the
Exchange would send a Request for Responses (``RFR'') message to all
members that have elected to receive such messages. Members would then
have 3 seconds to

respond with a price that would improve the proposed execution price
for the Agency Order, except that responses would not be entered for
the account of an options market maker from another options exchange.
Responses may be entered and executed at prices that are in a multiple
of the applicable minimum price increment that has been designated by
the Exchange for the series, which increment may not be less than
$0.01. The Exchange believes this would allow for greater flexibility
in pricing large-sized orders and provide for a greater opportunity for
price improvement.
    The Auction will conclude at the sooner of various conditions.\6\
At the conclusion of the Auction, the Agency Order would be executed
against the solicited order unless there is sufficient size to execute
the entire Agency Order at a price (or prices) that improves the
proposed crossing price. In the case where there is one or more public
customer orders resting in the book at the proposed execution price on
the opposite side of the Agency Order, the solicited order would be
cancelled and the Agency Order would be executed against other bids
(offers) if there is sufficient size at the bid (offer) to execute the
entire size of the Agency Order (size would be measured considering
resting orders and quotes and responses).\7\ If there is not sufficient
size to execute the entire Agency Order, the proposed cross would not
be executed and both the Agency Order and solicited order would be
cancelled. Additionally, the proposed cross would not be executed and
both the Agency Order and solicited order would be cancelled if the
execution price would be inferior to the BBO.
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    \6\ The Auction shall conclude at the sooner of: (i) The end of
the response period, (ii) upon receipt by the Hybrid Trading System
(``Hybrid'') of an unrelated order (in the same series as the Agency
Order) that is marketable against either the Exchange's disseminated
quote (when such quote is the NBBO) or the responses, (iii) upon
receipt by Hybrid of an unrelated limit order (in the same series as
the Agency Order and on the opposite side of the market as the
Agency Order) that improves any response, (iv) any time a response
matches the Exchange's disseminated quote on the opposite side of
the market from the responses, or (v) any time there is a quote lock
on the Exchange pursuant to CBOE Rule 6.45A(d) or 6.45B(d). See
paragraph (b)(2) of proposed CBOE Rule 6.74B, Solicitation Auction
Mechanism.
    \7\ When the Agency Order is executed at an improved price(s) or
at the proposed execution price against electronic orders, quotes
and responses, priority would be pursuant to the allocation
algorithm in effect pursuant to CBOE Rule 6.45A or 6.45B, as
applicable. The allocation for simple and complex orders would be
the same, except that complex orders would also be subject to the
complex order priority rules applicable to bids and offers in the
individual series legs of a complex order contained in paragraphs
(d) or .06 of CBOE Rule 6.53C, Complex Orders on the Hybrid System,
as applicable.
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    The proposed rule would also require members to deliver to
customers a written document describing the terms and conditions of the
Auction mechanism prior to executing Agency Orders using the Auction
mechanism. Such written document would be required to be in a form
approved by the Exchange.
    The proposed rule would also specify that members may not use the
Auction mechanism to circumvent the Exchange's rules limiting principal
order transactions.\8\ Additionally, the Exchange notes that for
purposes of paragraph (e) to CBOE Rule 6.9, Solicited Transactions,
which paragraph prohibits anticipatory hedging activities prior to the
entry of an order on the Exchange, the terms of an order would be
considered ``disclosed'' to the trading crowd on the Exchange when the
order is entered into the Auction mechanism.
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    \8\ See CBOE Rules 6.45A.01, 6.45B.01, 6.74, Crossing Orders,
and 6.74A.
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    Finally, the Exchange is proposing to expand its existing AIM
auction, which currently only applies to simple orders, to cover
complex orders. Thus, complex orders would be eligible for execution
through AIM at a net debit or net credit price provided the Auction
eligibility requirements of the AIM rule are satisfied and the Agency
Order is eligible for AIM considering its complex order type, order
origin code (i.e., non-broker-dealer public customer, broker-dealers
that are not Market-Makers or specialists on an options exchange, and/
or Market-Makers or specialists on an options exchange), class, and
marketability as determined by the Exchange. Allocation of complex
orders that are subject to AIM will be the same as the existing
allocation procedures, provided that the complex order priority rules
applicable to bids and offers in the individual series legs of a
complex order contained in CBOE Rule 6.53C(d) or 6.53C.06, as
applicable, will continue to apply. In addition, the Exchange is
proposing to provide in its rules that it may determine on a class-by-
class basis that orders of 500 or more contracts may be executed
through AIM without considering prices that might be available on other
options exchanges. All other aspects of the AIM auction will continue
to apply unchanged.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\9\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\10\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received from Members, Participants, or Others

    Written comments on the proposed rule change were neither solicited
nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) by order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2008-14 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2008-14. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the CBOE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2008-14 and should be
submitted on or before March 20, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-3729 Filed 2-27-08; 8:45 am]

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