[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40300-40301]
[FR Doc No: 2016-14599]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13102-003]

Birch Power Company; Notice of Application Ready for
Environmental Analysis and Soliciting Comments, Recommendations, Terms
and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original License (Major Project).
    b. Project No.: 13102-003.
    c. Date filed: July 2, 2013.
    d. Applicant: Birch Power Company.
    e. Name of Project: Demopolis Lock and Dam Hydroelectric Project.
    f. Location: At the U.S. Army Corps of Engineers' (Corps) Demopolis
Lock and Dam, on the Tombigbee River, west of the city of Demopolis in
Marengo and Sumter Counties, Alabama. The proposed project would occupy
approximately 23 acres of federal land administered by the Corps.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Nicholas E. Josten, GeoSense, 2742 Saint
Charles Ave, Idaho Falls, ID 83404,<PHONE_NUMBER>.
    i. FERC Contact: Adam Peer<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-13102-003.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted and is now ready for
environmental analysis.
    l. The proposed project would utilize the existing Corps' Demopolis
Lock and Dam and Reservoir, and would consist

of the following new facilities: (1) A 900-foot-long excavated intake
channel (headrace); (2) two 60-foot-long by 32-foot-wide trash racks
with 2.5-inch bar spacing; (3) a 201-foot-long by 80-foot-wide
powerhouse containing two 24-megawatt (MW) Kaplan turbines, having a
total installed capacity of 48 MW; (4) a substation; (5) a forebay
oxygen diffuser line system to enhance dissolved oxygen; (6) a 2,000-
foot-long excavated tailrace channel; (7) a 1,700-foot-long retaining
wall along the north side of tailrace channel; (8) a 4.4-mile-long,
115-kilovolt transmission line; and (9) appurtenant facilities. The
average annual generation would be about 213,000 megawatt-hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    All filings must (1) bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Public notice of the filing of the initial development
application, which has already been given, established the due date for
filing competing applications or notices of intent. Under the
Commission's regulations, any competing development application must be
filed in response to and in compliance with public notice of the
initial development application. No competing applications or notices
of intent may be filed in response to this notice.
    o. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.

    Dated: June 15, 2016.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2016-14599 Filed 6-20-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Page 37534]
[FR Doc No: 2023-12238]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP23-822-000.
    Applicants: MarkWest Pioneer, L.L.C.
    Description: Sec.  4(d) Rate Filing: Quarterly Fuel Adjustment
Filing to be effective 7/1/2023.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5136.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-823-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Amendment No.
142019-3--Mitsui to be effective 6/1/2023.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5143.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-824-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Periodic TCRA Filing--Texas
Eastern Refund to be effective 7/1/2023.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5144.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-825-000.
    Applicants: North Baja Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: NBX Project--Amended
Negotiated Rate and Non-Conforming Agmt No. 125154-1 to be effective 6/
1/2023.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5146.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-826-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Various June
1 2023 Releases to be effective 6/1/2023.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5166.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-827-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing--6/1/
2023 Chevron to be effective 6/1/2023.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5174.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-828-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements 6-1-23 to be effective 6/1/2023.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5187.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-829-000.
    Applicants: Equitrans, L.P.
    Description: Compliance filing: Notice Regarding Non-Certificated
Gathering Facilities--6/1/2023 to be effective N/A.
    Filed Date: 6/1/23.
    Accession Number: 20230601-5188.
    Comment Date: 5 p.m. ET 6/13/23.

    Docket Numbers: RP23-830-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate & Non-Conforming
Agreement--Antero 149760 to be effective 7/1/2023.
    Filed Date: 6/2/23.
    Accession Number: 20230602-5000.
    Comment Date: 5 p.m. ET 6/14/23.

    Docket Numbers: RP23-831-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Update (Hartree June 5, 2023) to be effective 6/5/2023.
    Filed Date: 6/2/23.
    Accession Number: 20230602-5063.
    Comment Date: 5 p.m. ET 6/14/23.

    Docket Numbers: RP23-832-000.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Sec.  4(d) Rate Filing: Small Customer Rate Schedule
Conversion to be effective 7/3/2023.
    Filed Date: 6/2/23.
    Accession Number: 20230602-5078.
    Comment Date: 5 p.m. ET 6/14/23.

    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 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP23-769-001.
    Applicants: North Baja Pipeline, LLC.
    Description: Compliance filing: NBX Project--Notice of Commencement
of Service CP20-27 to be effective N/A.
    Filed Date: 6/2/23.
    Accession Number: 20230602-5057.
    Comment Date: 5 p.m. ET 6/14/23.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: June 2, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-12238 Filed 6-7-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 149 (Friday, August 4, 2023)]
[Notices]
[Page 51811]
[FR Doc No: 2023-16699]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2511-000]

Hardy Hills Solar Energy LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Hardy Hills Solar Energy LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 21, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 31, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-16699 Filed 8-3-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Page 9713]
[FR Doc No: 2015-03748]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-1041-000]

Prairie Breeze Wind Energy II LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Prairie Breeze Wind Energy II LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 10, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: February 18, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-03748 Filed 2-23-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45251-45253]
[FR Doc No: 2018-19353]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence
for Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Guidance for Industry and Food and Drug
Administration Staff; Section 905(j) Reports: Demonstrating Substantial
Equivalence for Tobacco Products.''

DATES: Submit either electronic or written comments on the collection
of information by November 5, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 5, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0147 for ``Guidance for Industry and Food and Drug
Administration Staff; Section 905(j) Reports: Demonstrating Substantial
Equivalence for Tobacco Products.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and

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

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry and Food and Drug Administration Staff on Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products

OMB Control Number 0910-0673--Extension

    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) by adding, among other things, a chapter
granting FDA authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors.
    The FD&C Act, as amended by the Tobacco Control Act, requires that
before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, the new tobacco product must
undergo premarket review by FDA. FDA must issue an order authorizing
the commercial distribution of the new tobacco product or find the
product exempt from the requirements of substantial equivalence under
section 910(a)(2)(A) of the FD&C Act, before the product may be
introduced into commercial distribution (section 910 of the FD&C Act
(21 U.S.C. 387j)).
    FDA has issued a guidance document containing recommendations for
preparing substantial equivalence reports (SE Reports) under section
905(j)(1)(A)(i). A tobacco product manufacturer must show that a new
tobacco product is substantially equivalent, within the meaning of
section 910, to a tobacco product commercially marketed (other than for
test marketing) in the United States as of February 15, 2007, or to a
tobacco product that the Secretary has previously determined, pursuant
to subsection (a)(3) of section 910, is substantially equivalent and
that it is in compliance with the requirements of the FD&C Act. The
comparison product chosen by the tobacco product manufacturer is
referred to by FDA as the predicate tobacco product.
    The guidance document associated with this collection of
information contains recommendations on preparing reports intended to
demonstrate substantial equivalence to a predicate tobacco product and
compliance with the FD&C Act as required under section 905(j)(1)(A)(i).
Submission of a section 905(j)(1)(A)(i) report intended to demonstrate
substantial equivalence and, in response, an order from the Agency
finding that the new tobacco product is substantially equivalent to a
predicate tobacco product and in compliance with the requirements of
the FD& C Act, is one means for a new tobacco product to legally enter
the market. FDA's guidance entitled ``Demonstrating the Substantial
Equivalence of a New Tobacco Product: Responses to Frequently Asked
Questions'' (December 2016). This guidance may be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm). In that guidance, FDA recommends that certain
modifications might be addressed in a ``Product Quantity Change
Report,'' which is a more streamlined SE Reports for certain
modifications that should be easier for manufacturers to prepare.
    The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to Chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah, pipe tobacco,
nicotine gels, dissolvables that were not already subject to the FD&C
Act, and other tobacco products that may be developed in the future (81
FR 28974 at 28976) (``the Deeming final rule'').
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and                  683               1             683             300         204,900
 910(a).........................
Full SE 905(j)(1)(A)(i) and                  456               1             456              90          41,040
 910(a) Bundled.................
Product Quantity Change SE                   239               1             239              87          20,793
 Report.........................
Product Quantity Change Bundled              192               1             192              62          11,904
 SE Report......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         278,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimates are based on experience with SE Reports, initial
updated deemed registration and listing data, interactions with the
industry, and information related to other regulated products. The
estimated number of SE Reports is expected to increase from an annual
average of 979 to 1,570.
    When groups of full or product quantity change SE Reports have
identical content, they may be bundled; when a group of similar reports
are bundled, the subsequent bundled reports are expected to take less
time to prepare than the initial report.
    FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the substantial equivalence requirements of sections
905(j)(1)(A)(i) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)) for an
SE application.
    FDA estimates that 683 respondents will prepare and submit 683
section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone
submitting an SE Report is required to submit an environmental
assessment (EA) under 21 CFR 25.40. The burden for environmental
reports has been included in the burden per response for each type of
SE report. Based on FDA's experience with EAs for currently regulated
tobacco products, we expect industry to spend 80 hours to prepare an
environmental assessment for a SE Report. Thus, FDA estimates that it
will take a manufacturer approximately 300 hours per report to prepare
an SE Report and the EA for a new tobacco product, which is a total of
204,900 hours.
    In addition, we estimate receiving 456 Full SE Bundled Reports at
90 hours per submission for a total of 41,040 hours.
    FDA estimates that it will receive 239 Product Quantity Change SE
Reports and that it will take a manufacturer approximately 87 hours to
prepare this report for a total of 20,793 hours. This includes time to
prepare the environmental assessment, which FDA believes will take less
time due to the typically more limited modification(s) included in a
Product Quantity Change SE Report. We estimate receiving 192 Product
Quantity Change Bundled SE Reports at approximately 62 hours per
submission for a total of 11,904 hours, this number excludes the time
for the initial SE Report which was previously account for.
    Therefore, FDA estimates the burden for submission of SE
information will be 278,637 hours. This is an increase of 106,759 hours
from the currently approved burden. We attribute this increase to an
increase in the number of SE Reports we expect related to Deemed
products (e.g., based on the initial registration and listing
information).

    Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19353 Filed 9-5-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Rules and Regulations]
[Pages 30157-30158]
[FR Doc No: 2015-12737]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0402]

Drawbridge Operation Regulations; James River, Isle of Wight and
Newport News, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the James River Draw Bridge across the
James River, mile 5.0, between Isle of Wight and Newport News, VA. This
deviation is necessary to facilitate electrical repairs to the south
tower of the bridge. This deviation allows the bridge to remain in the
closed-to-navigation position.

DATES: This deviation is effective from 8 a.m. to 8 p.m. on June 8,
2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0402], is

available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH''. Click on Open Docket Folder on the
line associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Hal R. Pitts, Bridge
Administration Branch Fifth District, Coast Guard; telephone (757) 398-
6222, email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
who owns and operates the James River Draw Bridge, has requested a
temporary deviation from the current operating regulations set out in
33 CFR 117.5, to facilitate electrical repairs on the south tower of
the bridge.
    Under the regular operating schedule, the James River Draw Bridge,
mile 5.0, between Isle of Wight and Newport News, VA, opens on signal.
The bridge is a vertical lift draw bridge and has a vertical clearance
in the closed position of 60 feet above mean high water.
    Under this temporary deviation, the bridge will be closed to
navigation from 8 a.m. to 8 p.m. on June 8, 2015.
    The James River is used by a variety of vessels including
freighters, tugs, and recreational vessels. The Coast Guard has
carefully coordinated the restrictions with commercial and recreational
waterway users.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will not be able to open for emergencies
and there is no alternate route for vessels to pass for vessels unable
to pass through the bridge in the closed position. The Coast Guard will
also inform the users of the waterways through our Local and Broadcast
Notice to Mariners of the change in operating schedule for the bridge
so that vessels can arrange their transits to minimize any impacts
caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: May 15, 2015.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2015-12737 Filed 5-26-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 153 (Thursday, August 8, 2013)]
[Notices]
[Pages 48516-48518]
[FR Doc No: 2013-19148]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70101; File No. SR-Phlx-2013-78 ]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Trading Halts or Suspension When an Exchange Trading System Experiences
Technical Failure or Failures

August 2, 2013.
    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 July 25, 2013, NASDAQ OMX PHLX LLC (``Phlx'' 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 prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Exchange Rules 1047 and 1047A to
expressly state another factor that is considered in determining
whether trading on the Exchange in any class of option contracts should
be halted or suspended.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, 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
    The Exchange is proposing to amend Exchange Rule 1047, entitled
``Trading Rotations, Halts and Suspensions'' and Rule 1047A, entitled
``Trading Rotations, Halts or Reopenings'' to expressly state a factor
which is considered today in determining whether to halt or suspend
trading in any class of option on the Exchange. Today, Exchange Rule
1047 contains four factors that an Options Exchange Official \3\ may
consider appropriate in the interests of a fair and orderly market and
to protect investors when determining whether to halt or suspend
options trading. The current factors are as follows: (i) Trading in the
underlying stock or Exchange-Traded Fund Share has been halted or
suspended in the primary market; (ii) the opening of such underlying
stock or Exchange-Traded Fund Share in the primary market has been
delayed because of unusual

circumstances; (iii) the Exchange has been advised that the issuer of
the underlying stock or Exchange-Traded Fund Share is about to make an
important announcement affecting such issuer; or (iv) other unusual
conditions or circumstances are present. This fourth factor is the
basis on which Options Exchange Officials today halt or suspend options
trading for technical issues on Phlx.
---------------------------------------------------------------------------

    \3\ See Rule 1. An ``Option Exchange Official'' is an Exchange
staff member or contract employee designated as such by the Chief
Regulatory Officer. A list of individual Options Exchange Officials
shall be displayed on the Exchange Web site. The Chief Regulatory
Officer shall maintain the list of Options Exchange Officials and
update the Web site each time a name is added to, or deleted from,
the list of Options Exchange Officials. In the event no Options
Exchange Official is available to rule on a particular matter, the
Chief Regulatory Officer or his/her designee shall rule on such
matter.
---------------------------------------------------------------------------

    The Exchange is proposing to expressly state that technical
failures may be considered when determining to halt or suspend options
trading. Specifically, the Exchange proposes to expressly note that an
Options Exchange Official may consider a Trading System technical
failure or failures including, but not limited to, the failure of the
central processing system, a number of member or member organization
trading applications, or the electrical power supply to the system
itself or any related system in determining when to halt or suspend
options trading. The Exchange proposes to define Trading System for
purposes of this Rule as Phlx XL II, or any other Exchange quotation,
transaction reporting, execution, order routing or other systems for
trading options.
    The Exchange believes that a Trading System failure may be
considered as an unusual condition or circumstance as noted in Rule
1047(iv) and Rule 1047A(iii), however the Exchange desires to include
specific language regarding a technical failure within the list of
considerations, similar to other options exchanges. Today, this factor
is included in the list of factors for halting or suspending options
trading on The NASDAQ Options Market LLC (``NOM'') and the NASDAQ OMX
BX, Inc. (``BX Options'').\4\ NOM and BX Options today halt or suspend
options trading for technical failures utilizing the corresponding
rules at Chapter V, Section 3. The Exchange believes that expressly
stating this factor within Rules 1047 and 1047A will provide clearer
guidance to Options Exchange Officials when they are determining
whether to halt or suspend options trading on Phlx.
---------------------------------------------------------------------------

    \4\ See NOM and BX Options Rules at Chapter V, Section 3.
---------------------------------------------------------------------------

    Similarly, the Exchange proposes to add identical language to Rule
1047A which relates to the trading of options on indices. Rule 1047A
currently provides that ``[t]rading on the Exchange in any option may
be halted with the approval of an Options Exchange Official, whenever
trading on the primary market in any underlying security is halted or
suspended. Trading shall be halted whenever an Options Exchange
Official deems such action appropriate in the interests of a fair and
orderly market and to protect investors. Among the factors that may be
considered are the following: (i) Trading has been halted or suspended
in the market that is the primary market for a plurality of the
underlying stocks; (ii) the current calculation of the index derived
from the current market prices of the stocks is not available; (iii)
other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present.'' The Exchange
proposes to amend Rule 1047A by adding identical language to that
proposed for Rule 1047. The Exchange also proposes to renumber Rules
1047 and 1047(A) to include the added factor.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ in particular, in that it is designed to promote
just and equitable principles of trade, to 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,
by specifically noting that Options Exchange Officials may consider
technical failures when halting or suspending options trading.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that expressly noting that a system technical
failure should be among the factors considered by an Options Exchange
Official in halting or suspending options trading provides greater
clarity to the factors which may cause such a market halt or
suspension. Today, a technical failure of either the exchange's Trading
System or that of a number of Participants would be considered in
halting or suspending options trading on NOM and BX Options.\7\ An
Options Exchange Official must determine whether halting or suspending
options trading is appropriate to ensure a fair and orderly market and
also to protect investors. Options Exchange Officials must consider the
factors enumerated within Rules 1047 and 1047A, depending on the
options impacted, and make decisions as to whether to halt or suspend
trading after an analysis of the facts. The Exchange believes that
expressly noting Trading System failures as a consideration is
appropriate because such failures could prevent a fair and orderly
market and impact investors. The Exchange believes that the addition of
the proposed text provides greater clarity to the factors to be
considered by Options Exchange Officials.
---------------------------------------------------------------------------

    \7\ See NOM and BX Options Rules at Chapter V, Section 3.
---------------------------------------------------------------------------

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 not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes this
proposed rule change will benefit investors by specifically noting that
technical issues are a consideration for an Options Exchange Official
when determining whether to halt or suspend options trading. Today, the
Exchange halts and suspends options trading for such technical failures
when those failures impact investors as do other options exchanges.
This proposal will provide greater clarity to Options Exchange
Officials in making these determinations.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \9\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved. The Exchange has
provided the Commission

written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2013-78 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2013-78. This file
number should be included on the subject line if email 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. 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-Phlx-2013-78 and should be
submitted on or before August 29, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19148 Filed 8-7-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 153 (Thursday, August 8, 2013)]
[Rules and Regulations]
[Pages 48315-48318]
[FR Doc No: 2013-19213]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0497]
RIN 1625-AA00

Safety Zone; North Hero Air Show; North Hero, VT

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters east of North Hero Island in Lake Champlain for the
North Hero Air Show, an event to be held over the water. This temporary
final rule is necessary to provide for the safety of life on the
navigable waters east of North Hero Island during an air show of low-
flying, high-speed, and high-performance acrobatic aircraft that could
pose an imminent hazard to vessels operating in the area. This zone
will close all waters in an area approximately 2 nautical miles by \1/
2\ nautical mile east of North Hero Island in North Hero, VT for the
duration of the air show. Persons or vessels may not enter into this
zone unless authorized by the Captain of the Port, Sector Northern New
England.

DATES: This rule is effective from 9 a.m. on August 11, 2013, until 9
p.m. on August 12, 2013. This rule will be enforced from 9 a.m. until 9
p.m. daily on August 11, 2013, and August 12, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0497]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Megan L. Drewniak, Waterways Management
Division at Coast Guard Sector Northern New England, telephone 207-741-
5421, email<EMAIL_ADDRESS>If you have questions on viewing
or submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final 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 the Coast Guard did not receive the
necessary information for this even in sufficient time to publish an
NPRM. The nature of this event has changed and the sponsor would like
to include a low flying aerobatic air show over the water and drop
grapefruits at a water target as part of a fundraising event. Per
Federal Aviation Administration requirements, no vessels are permitted
to transit during aerobatic maneuvers. This regulation is necessary to
ensure the immediate safety of users of the waterway.

B. Basis and Purpose

    The legal basis for the temporary rule is 33 U.S.C. 1231, 46 U.S.C.
Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Pub. L. 107-295, 116 Stat.
2064; and Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to define safety zones.
    The safety zone is being issued to ensure the safety of persons and
vessels east of North Hero Island for the duration of the air show.

C. Discussion of the Rule

    During this air show there will be low flying planes conducting
aerobatic maneuvers east of North Hero Island in Lake Champlain within
the confines of the safety zone and dropping grapefruits onto water
targets as part of a fundraising event. This safety zone will be in
effect from 9 a.m. to 9 p.m. on August 11 and August 12, 2013.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The economic effect of this rule will not be significant for the
following reasons: The safety zone will be of limited duration. Vessels
may be authorized to transit the zone with permission of the Captain of
the Port, Sector Northern New England. The aerobatic box is a rectangle
2 nautical miles by \1/2\ nautical mile, parallel to the shoreline,
with its western edge 500 feet offshore. Vessels transiting to or from
the shoreline may transit around the safety zone with limited delay.
Additionally, maritime advisories will be broadcasted during the
duration of the enforcement period.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
    (1) Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we
have considered whether this rule would have a significant economic
impact on a substantial number of small entities. 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.
    This rule may affect the following entities, some of which may be
small entities: the owners or operators of vessels intending to transit
the safety zone. However, this rule will not have a significant
economic impact on a substantial number of small entities due to the
geographic location in which this rule takes place and advance
notifications will be made to the local community by marine information
broadcasts. Additionally, mariners may transit around the safety zone
to gain access to or from the shoreline without a significant delay.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement

Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    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.

4. 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).

5. Federalism

    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 determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. 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.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (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 is categorically excluded from further review
under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion Determination will be available in the docket
where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 46 U.S.C. 701, 3306, 3703; 50 U.S.C.
191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116
Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T01-0497 to read as follows:

Sec.  165.T01-0497  Safety Zone; North Hero Air Show, North Hero, VT.

    (a) Location. The safety zone will include all navigable waters
surface to bottom beginning with the following coordinate:
44[deg]48'24'' N, 73[deg]17'02'' W; thence southeast approximately 500
feet to position 44[deg]48'22'' N, 73[deg]16'46'' W; thence southwest
to position 44[deg]47'53'' N, 73[deg]16'54'' W; thence northwest to
position 44[deg]47'54'' N, 73[deg]17'09'' W.
    (b) Enforcement and Effective dates. This rule is effective from 9
a.m. on August 11, 2013, until 9 p.m. on August 12, 2013. This rule
will be enforced from 9 a.m. until 9 p.m. daily on August 11, 2013, and
August 12, 2013.
    (c) Regulations. (1) The general regulations contained in 33 CFR
165.23 apply. During the enforcement period, entry into, transiting,
mooring, anchoring or remaining within this safety zone is prohibited
unless authorized by the Captain of the Port or his designated
representatives.
    (2) This temporary safety zone is closed to all vessel traffic,
except as may be permitted by the Captain of the Port or his designated
on-scene patrol personnel. Vessel operators given permission to enter
or operate in the safety zone must comply with all directions given to
them by the Captain of the Port or his designated representatives.
    (3) Persons and vessels may request permission to enter the Safety
Zone by

contacting the COTP or the COTP's on-scene representative on VHF-16 or
via phone at<PHONE_NUMBER>.
    (4) The ``designated representative'' is any Coast Guard
commissioned, warrant, or petty officer who has been designated by the
Captain of the Port to act on his behalf. The on-scene representative
may be on a Coast Guard vessel, a Coast Guard Auxiliary vessel, or
onboard a local or state agency vessel that is authorized to act in
support of the Coast Guard. Additionally, the Coast Guard Auxiliary may
be present to inform vessel operators of this regulation.
    (5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel must proceed
as directed.

    Dated: June 24, 2013.
B.S. Gilda,
Captain, U.S. Coast Guard, Captain of the Port Sector Northern New
England.
[FR Doc. 2013-19213 Filed 8-7-13; 8:45 am]
BILLING CODE 9110-04-P